1. NIDA CTN 0051: A Multi-site Randomized Controlled Evaluation of Extended-Release
Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT). (LIs Rotrosen & Nunes).
This study will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®) versus buprenorphine naloxone (BUP-NX, Suboxone®) as pharmacotherapeutic aids to recovery amongst treatment-seeking participants who have completed detoxification and achieved short term abstinence. The primary objective is to compare the effectiveness of XR-NTX versus BUP-NX in promoting the joint outcome of sustained retention in treatment and abstinence after an index admission for opioid dependence. A rescue protocol will enable the study to address additional questions regarding the sequencing of treatments. Status: Enrollment project to begin in April of 2013
2. NIDA CTN 0052: A Multi-site Randomized Double Blind Placebo Controlled Evaluation
of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence. (LI Winhusen).
The primary objective of this study is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment. Reference: Winhusen T, Brady, K, Stitzer M, Woody G, Lindblad R, Kropp, F, Brigham G, Liu, D, Sparenborg, S, Sharma, G, VanVeldhuisen, Adinoff, B, Somoza, E. (In press). Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: An efficacy trial conducted in the real world. Contemporary Clinical Trial. Status: Open for enrollment
3. NIDA R34 A Randomized Pilot Trial Comparing Methods for Reaching Non-system
Engaged, Substance Abusing Homeless Youth. (PI Slesnick).
This study provides the first formal test of an outreach intervention for substance abusing homeless youth who are not connected to services. Non- service connected homeless youth (N = 60) will be randomly assigned to one of two outreach conditions with the goal to engage youth to either a crisis shelter or to a drop-in center. The outreach worker will meet with the youth for 6 months to assist the youth's navigation of the service system. Follow-up will be conducted at 3, 6 and 9 months post-baseline. If successful, this study will provide important documentation of successful strategies to reach and engage these vulnerable youth into services.
Status:Open for enrollment
4. NIDA CTN 0048: A Multi-site Randomized Double Blind Controlled Evaluation of
Buprenorphine for Cocaine Use Reduction (CURB). (LI Ling).
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence. Eleven CTP study sites will enroll 300 cocaine-dependent participants who also meet criteria for either past-year opioid dependence or past-year opioid abuse or past-year opioid use with a history of opioid dependence during the lifetime.
Status: Enrollment Complete
a. NIDA 0048A: A Study of the Pharmacogenetics of Buprenorphine/Naltrexone for
Cocaine Dependence in the CURB Study. (LIs Nielsen & Kosten) This study aims to test whether genetic markers in the mu, kappa and nociceptin/orphanin FQ, OPRL1 receptors are associated with the efficacy of buprenorphine and naltrexone (BUP/NTX) for individuals with cocaine use disorder. Investigators hypothesize that patients with the functional mu polymorphism of OPRM1, rs1799971, A118G, which is a non-synonymous Asn to Asp substitution, will have a greater reduction in cocaine use than those without this polymorphism. This hypothesis is based on the reduced rate of relapse during naltrexone treatment in alcoholic patients with this polymorphism compared to those without this polymorphism (Oslin 2006; Arias 2006). They will also explore several polymorphisms in the kappa and nociceptin/orphanin FQ neurotransmitter systems for their potential effects on treatment response to BUP/NTX based on protective associations of several of these polymorphisms with cocaine and other drug abuse. Status: Enrollment Complete
5. NIDA RO1 A randomized Clinical Trial Evaluating Family Therapy in the home vs.
Family Therapy in the Office vs. Women’s Health Education, for Mothers of Adolescent Children in Outpatient SUD Treatment (PI Slesnick).
The primary objective of this NIDA sponsored randomized clinical trial is to evaluate the relative effectiveness of (1) family therapy conducted in the home, (2) family therapy conducted in the office, and (3) women’s health education for reducing substance abuse, individual, and family problems among adult women in substance abuse treatment and their adolescent children. (PI Slesnick)
Status:Open for enrollment
6. NIDA K23 Community Reinforcement and Family Training for Treatment
Retention/HIV Risk Behavior Reduction. (PI Brigham).
The purpose of this NIDA sponsored randomized clinical trial is to compare two approaches to involving friends and relatives of persons with substance use disorders in that person’s treatment. One type of treatment is called Community Reinforcement and Family Training to Increase Drug Abuser’s Retention in Treatment and Reduce HIV Risk (CRAFT-TX). The other type of treatment is called treatment-as-usual (TAU). The study will determine if one of these two methods works better than the other to help concerned friends and relatives convince a person with a substance use disorder to remain in treatment and other recovery activities for their drug dependence problem.
Reference: Brigham, GS, Slesnick, N., Somoza, E., Horn, P., and Rich, J., (2009). Community Reinforcement and Family Training for Treatment Retention and HIV Behavioral Risk Reduction: A Study Protocol. Journal of Behavior Analysis in Health, Sports, Fitness, and Medicine, 2(1), 91-108. . Status: Complete
7. NIDA CTN 0046: Smoking Cessation and Stimulant Treatment (S-CAST): A
Randomized Controlled Evaluation of the Impact of Concurrent Outpatient Smoking Cessation and Stimulant Treatment on Stimulant Dependence. (LI Winhusen)
The primary objective of this study is to evaluate the impact of substance abuse treatment as usual plus smoking cessation treatment (TAU+SCT), relative to substance abuse treatment as usual (TAU), on drug abuse outcomes. This is a 10-week, intent-to-treat, 2- group randomized controlled trial with follow-up visits at 3 and 6 months post-smoking quit date. Eligible participants will be randomized to the TAU+SCT or TAU arm. Participants randomized to the TAU+SCT arm will have a target quit smoking day at the end of study week 3. Participants randomized to the TAU+SCT arm will receive individual smoking-cessation counseling consisting of approximately one ten-minute counseling session per week during study weeks 1 through 10. In addition, all TAU+SCT participants will receive extended-release (XL) bupropion (300 mg/day) and, during the post-quit treatment phase, nicotine inhaler (6-16 cartridges per day ad libitum). Finally, all TAU+SCT participants will receive contingency management in which drawings for prizes are given for smoking abstinence as assessed by carbon monoxide (CO) levels during the post-quit phase of the trial (i.e., weeks 4-10). The study will evaluate whether concurrent smoking cessation treatment improves, worsens, or has no effect on drug abuse outcomes in smokers who are in outpatient substance abuse treatment for cocaine or methamphetamine dependence. Secondary objectives include evaluating: 1) the efficacy of TAU+SCT, relative to TAU, in improving smoking outcomes; 2) the safety of TAU+SCT relative to TAU. The study has a target recruitment total of 528 participants to be enrolled from 12 CTPs. Reference: Winhusen T, Stitzer M, Woody G, Brigham G, Kropp F, Ghitza U, Lindblad R, Adinoff B, Green C, Sharma G, Somoza E. (In press), Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals. Contemporary Clinical Trial. Status: Complete
a. CTN-0046-A-1 Site Influences on Treatment Effects – Smoking-Cessation and
Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcome. Site variations in study outcomes are apparent in clinical trials conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). Systematic and standardized collection of organizational and workforce variables may help elucidate site variations and increase the CTN’s understanding of patient outcomes in protocols. The Smoking-Cessation and Stimulant Treatment (CTN-0046) will be used to assess the influence of organizational and workforce characteristics on trial operations (e.g., rates of participant recruitment and follow-up) and patient outcomes (e.g., reductions in drug use). This study will build on the analysis of organizational and workforce data in the Baseline Protocol (CTN-0008) and the collection of pre-implementation site data for STAGE-12 (CTN-0031-A-3). The study’s specific aim is the assessment of associations between site organizational and practitioner variables and site differences in clinical trial outcomes.
8. NIDA RC1 Comparing Acute and Continuous Drug Abuse Treatment: A Randomized
The purpose of this NIDA sponsored randomized clinical trial is compare the effectiveness of an episodic care model (TAU) and a continuous care model (LTRM) of substance abuse treatment among drug dependent adults. The proposed LTRM treatment blends the Community Reinforcement Approach (CRA), Contingency Management (CM), and Facilitated Therapeutic Alliance (FTA), each with demonstrated efficacy, to address addiction as a chronic disease. In contrast with previous continuing care approaches, LTRM will be initiated very early in outpatient treatment, rather than after treatment completion.
Reference: Brigham, G.S., Carlson, R., Booth, B. & Flack, R. (June, 2011). Findings from two studies of long term recovery management for persons with stimulant or opiate dependence. CPDD, Hollywood, Fl. Status:Complete
9. NIDA CTN 0031: Stimulant Abuser Groups to Engage in 12-Step (STAGE-12):
Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by increasing 12-Step Involvement. (LI Donovan)
The primary objective of this protocol was to evaluate the degree to which a combined group and individual 12-Step facilitative intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant abusers. For this protocol, STAGE-12 will be integrated into treatment as usual. The primary objective is to evaluate reduction in percent of days of stimulant use as measured by self-report. This is a randomized, 2-group design comparing STAGE-12 integrated into TAU (STAGE-12 /TAU) to TAU without STAGE-12 for stimulant abusers receiving formal substance abuse treatment in participating community-based treatment programs (CTP). A total of 471 stimulant users seeking formal treatment, recruited from 10 CTPS, were randomized. Primary Outcome: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU.
Reference: Donovan, D.M., Daley, D.C., Brigham, G.S., Hodgkins, C. C., Perl, H.I., Garrett, S.B., Doyle, S.R., Floyd, A.S., Knox, P.C., Botero, C., Kelly, T.M., Killeen, T.K., Hayes, C. , Kau'iBaumhofer, N., Seamans, C., Zammarelli, L. (In press).Stimulant abuser groups to engage in 12-Step: A multisite trial in the National Institute on Drug Abuse Clinical Trials Network. Journal of Substance Abuse Treatment.
a. CTN-0031-A-1 An Evaluation of Neurocognitive Function, Oxidative Damage,
and their Association with Treatment Outcomes in Methamphetamine and Cocaine Abusers. The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with METH use disorders. Secondary objectives include evaluating whether: 1.) performance on various neurocognitive tests, including the Stroop, Rey Auditory-
Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), and the Barratt Impulsiveness Scale version -11 (BIS-11) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers; 2.) neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers; 3.) oxidative damage, as assessed by two plasma measures, is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers, and 4.) oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group. Status: Complete
b. CTN-0031-A-2 The Role of Alcohol Consumption in Classifications of Alcohol
Use Disorders: A Clinical Study (Collaboration with and support from NIAAA).
This study will investigate the utility of adding a frequency measure of alcohol consumption to the DSM-V diagnostic criteria for alcohol use disorders, by analyzing the statistical performance of the alcohol consumption measure in conjunction with the other DSM-IV alcohol abuse and dependence criteria arrayed along a continuum of severity in clinical samples. The alcohol consumption measure will be the frequency of drinking 5+ drinks (men) or 4+ drinks (women) on an occasion. To accomplish this goal, the study will collect baseline data in clinical samples on the 5+/4+ alcohol consumption measure and DSM-IV alcohol abuse and dependence criteria. These data will be used in two stages of analysis. First, it will conduct IRT analyses to determine whether the diagnostic criteria in conjunction with the 5+/4+ consumption measure form patterns similar to those found in the NESARC. In particular, it will focus on the role of the 5+/4+ consumption pattern when included in models that also include the DSM-IV alcohol abuse and dependence criteria. Second, it will determine whether the alcohol severity indicator derived from the first stage of analysis predicts repeated measures of alcohol consumption collected at the follow-up points in the study. Status: Complete
c. CTN-0031-A-3 Organizational and Practitioner Influences on Implementation of
STAGE-12. (Collaboration with NIDA DESPR). This project examines the organizational and counselor level factors that influence the eventual implementation of findings from the STAGE-12 clinical trial. Initial data collection at each of the sites took place prior to selection or training of study clinicians. Counselors and supervisors completed six research instruments and one semi-structured interview. This baseline data collection supported the development of an R01 application to conduct secondary analyses and evaluate implementation of the STAGE-12 intervention in the participating treatment centers during the protocol and after protocol completion. Status: Data
collection for this study completed; R01 grant has been awarded by NIDA to assess relationships relevant to the translation of research into practice: a) how the fidelity of STAGE-12 implementation affects client outcomes, b) whether commonly hypothesized counselor and organizational variables affect treatment fidelity, and c) uptake of the STAGE 12 intervention in participating clinics after the trial ends. Status:Complete
10. WSU Long Term Recovery Management (LTRM) for Chronic Cocaine Dependence a
Pilot Study. (PI Carlson & Brigham).
The purpose of this clinical pilot trial is to provide a preliminary assessment of a new treatment approach for persons with cocaine dependence. The overall purpose of the study is to develop and refine the new treatment and assess its acceptability to adults in treatment for crack-cocaine dependence. Importantly, this new approach views cocaine dependence as a long-lasting or chronic condition. The study is unique in that it combines several, well-known treatment methods: a) Community Reinforcement Approach, which is currently the standard treatment method in Maryhaven’s outpatient program; b) Contingency Management, which offers prizes for participating in certain recovery- related activities; and c) Facilitated Therapeutic Alliance, which helps people transition from working with one counselor to working with another counselor. The primary objective of this randomized clinical trial is evaluate the relative effectiveness of usual care for opiate of stimulant dependence and a continuous care model (Long Term Recovery Management) of substance abuse treatment among drug dependent adults. Reference: Brigham, G.S., Carlson, R., Booth, B. & Flack, R. (June, 2011). Findings from two studies of long term recovery management for persons with stimulant or opiate dependence. CPDD, Hollywood, Fl. Status:Complete
11. NIDA R01 Addressing Tobacco Through Organizational Change (ATTOC) in residential
addiction treatment settings. (PI Guydish).
This study assessed the effectiveness of a six month organizational change intervention, Addressing Tobacco Through Organizational Change (ATTOC), to improve how programs address tobacco dependence. The ATTOC intervention, implemented in three residential treatment programs, included consultation, staff training, policy development, leadership support and access to nicotine replacement therapy (NRT) medication. Program staff and clients were surveyed at pre- and post-intervention, and at 6 month follow-up. The staff survey measured knowledge of the hazards of smoking, attitudes about and barriers to treating smoking, counselor self-efficacy in providing such services, and practices used to address tobacco. The client survey measured knowledge, attitudes, and tobacco-related services received. NRT use was tracked.
Results: From pre- to post-intervention, staff beliefs became more favorable toward treating tobacco dependence (F(1, 163) = 7.15, p = 0.008), NRT use increased, and tobacco-related practices increased in a non-significant trend (F(1, 123) = 3.66, p = 0.058). Client attitudes toward treating tobacco dependence became more favorable (F(1, 235) = 10.58, p = 0.0013) and clients received more tobacco-related services from their program (F(1, 235) = 92.86, p < 0.0001) and from their counselors (F(1, 235) = 61.59, p < 0.0001). Most changes remained at follow-up. Conclusions: The ATTOC intervention can help shift the treatment system culture and increase tobacco services in addiction treatment programs. Reference: Guydish, J., Ziedonis, D., Tajima, B., Seward, G., Passalacqua, E., Chan, M., Delucchi, K., Zamarelli, L., Levy, M., Kolodziej, M., & Brigham, G., (2012). Addressing tobacco through organizational change (ATTOC) in residential addiction treatment settings. Drug and Alcohol Dependence, 121: 30-37.
12. NIDA CTN 0029: A Randomized Controlled Clinical Pilot Study of Osmotic-Release
Methylphenidate (OROS-MPH) in Initiating and Maintaining Abstinence in Smokers with Attention Deficit Hyperactivity Disorder (ADHD). (LI Winhusen)
The primary objective of this study was to evaluate whether OROS-MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study involved 255 participants, recruited from six sites. Primary Findings: Prolonged abstinence rates for the OROS-MPH and placebo groups did not differ significantly. OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated. Reference: Winhusen T, Somoza E, Brigham G, Liu D, Green CA, Covey L, Croghan I, Adler L, Weiss R, Leimberger J, Lewis D, Dorer E., (2010). Impact of attention- deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial. Journal of Clinical Psychiatry. PMID: 20492837 Status:Complete
13. NIDA R01 Clinical Supervisory Relationships and Turnover: A Longitudinal
This nationwide study, annually tracked a cohort of 598 substance use disorder counselors over a four-wave period to document the cumulative rates of voluntary turnover and examine how counselor perceptions of the organizational environment and clinical supervisor leadership effectiveness predict voluntary turnover over time. Survey data were collected from counselors in Year 1, and actual turnover data were collected from organizational records in Years 2, 3, and 4. Primary Findings: Twenty-five percent of the original counselors turned over by Year 2, 39% by Year 3, and 47% by Year 4. Counselors with more favorable perceptions of the organizational environment are between 13.8% and 22.8% less likely to turn over than those with less favorable perceptions. None of the leadership effectiveness variables were significant. Reference: Eby, L. T., & Rothrauff-Laschober, T. C. (2012). The relationship between perceptions of organizational functioning and voluntary counselor turnover: A four-wave longitudinal study. Journal of Substance Abuse Treatment, 42(2), 151-158. doi Status:Complete
14. NIDA CTN 0015: Women’s Treatment for Trauma and Substance Use Disorders: A
Post-Traumatic Stress Disorder (PTSD) is common among people with substance use disorders, and patients suffering from both of these conditions have a more difficult time meeting their treatment goals. Estimates suggest that as many00 as 80% of women seeking treatment for drug abuse report lifetime histories of sexual and/or physical assault. These facts highlight the importance of finding effective treatments for this high- risk population. Early studies showed that Seeking Safety, a treatment designed specifically for patients with PTSD and substance use disorders, held great potential for this population. This study compared the effectiveness of Seeking Safety added to substance abuse treatment-as-usual (TAU) with Women’s Health Education added to TAU. The researchers looked at the effect of these treatment options on both substance use and the severity of PTSD symptoms. Primary Findings: Analyses showed large, clinically significant reductions in PTSD symptoms over the course of treatment and follow-up, but no reliable difference between the study groups. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline. Seeking Safety therapy was not associated with increases in substance use, adverse events, or dropout from treatment or study participation. The results reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co- occurring conditions. Reference: Hien, D. A., Wells, E. A., Jiang, H., Suarez-Morales, L., Campbell, A. N. C., Cohen, L. R., Miele, G. M., Killeen, T., Brigham, G. S., Zhang, Y., Hansen, C.,
Hodgkins, C., Hatch-Maillette, M., Brown, C., Kulaga, A., Kristman-Valente, A., Chu, M., Sage, R., Robinson, J. A., Liu, D., & Nunes, E. V. (2009). Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. Journal of Consulting and Clinical Psychology, 77, 607-619. doi: 10.1037/a0016227 PMID: 19634955 Status:Complete
15. NIDA CTN 0012: Characteristics of Screening, Evaluation, and Treatment of HIV/AIDS,
Hepatitis C Viral Infection, and Sexually Transmitted Infections in Substance Abuse Treatment Programs (LI Brown)
Substance abuse is associated with a wide spectrum of medical disorders, including infections due to the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV) as well as sexually transmitted infections. Despite the seriousness of this problem, there has not been a systematic investigation of infectious disease services in the substance abuse treatment health care delivery system. This study surveyed CTP administrators and direct care providers, and reviews policies related to clinical guidelines and reimbursement through a survey of administrators of state substance abuse agencies or health departments. Primary Findings: Treatment programs varied in corporate structure, source of revenue, patient census, medical services, counseling services and staff education targeted HIV/AIDS more often than HCV or STI. The results of this study have already served as hypothesis generator for prospective HIV studies at the CTN. In addition to filling the information gap about available services for infectious disease in substance abuse treatment programs, this study provides a basis for future studies on the efficiency of these services and of health outcomes. Reference: Brown, L., et al. (2007). Health services for HIV/AIDS, HCV, and sexually transmitted infections in substance abuse treatment programs. Public Health Reports 122:441-445. Status: Complete
16. NIDA CTN 0008: Assessment of the National Drug Abuse Clinical Trials Network: A
Baseline for Investigating Diffusion of Innovation. (LI McCarty)
The ‘Baseline Study’ was designed to help us better understand the Community Treatment Programs participating in the NIDA Clinical Trials Network (CTN). Using a series of surveys, the study sought to 1) describe the programs and practitioners delivering drug abuse treatment services within the CTN; 2) build a system that can track changes in program and staff characteristics; 3) allow treatment program managers to compare their program to others—both within the CTN and nationwide; and 4)promote studies of organizational change and the characteristics that predict whether research-based treatment strategies will become part of usual treatment in a program.
Primary Findings: The surveys describe 106 corporations (95% response rate) providing drug abuse treatment in 348 treatment units (91% response rate). Most treatment units are not-for-profit and are not affiliated with health care or mental health care organizations and tend to be larger than the modal drug abuse treatment program. In the CTN, hospital- based services are over-represented and programs based in mental health centers are under-represented. The treatment units serve a heterogeneous patient population, and the inpatient, residential, methadone, and outpatient levels of care vary in the services provided. Reference: McCarty, D., et al. (2008). Treatment programs in the National Drug Abuse Treatment Clinical Trials Network. Drug & Alcohol Dependence 92:200-207. Status:Complete
17. NIDA CTN 0001: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate
Detoxification: A Multi-site Randomized Clinical Trial. (LI Ling)
The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in inpatient and outpatient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network. DESIGN: DSM-IV-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2:1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine. A total of 113 inpatients (77 bup-nx, 36 clonidine) and 231 outpatients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings.
Primary Findings: A total of 59 of the 77 (77%) inpatients assigned to the bup-nx condition achieved the treatment success criterion compared to 8 of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) outpatients assigned to the bup-nx condition achieved the treatment success criterion, compared to 74 (5%) assigned to clonidine. The study supported the benefits of Bup/Nx for opioid detoxification in inpatient treatment programs and illustrated important ways in which clinical research can be conducted in community treatment programs. Dissemination: This CTN protocol was selected for development as a NIDA/SAMHSA Blending Team product. Reference: Ling, W., Amass, L., Shoptaw, S., Annon, J., Hillhouse, M., Babcock, D., Brigham, G., Harrer, J., Reid, M., Muir, J., Buchan, B., Orr, D., Woody, G., Krejci, J., Ziedonis, D., and the Buprenorphine Study Protocol Group (2005). A multi center
randomized trial of Buprenorphine-naloxone versus Clonidine for opioid detoxification: Findings from the National Institute on Drug Abuse Clinical Trials Network. Addiction, 100, 1090-1000. PMID:16042639
18. Fakeability of the University of Rhode Island Change Assessment with a substance abuse
The purpose of this study was to measure the effect of intentional faking on URICA test scores in a population of individuals seeking chemical dependency treatment. The major research questions were: (1) To what extent are subjects able to fake on each of the URICA subscales? (2) What is the profile or template of the typical fake response? and (3) What are the implications of faking on the URICA for research and application of a stages of change model in the field of chemical dependency treatment? One hundred fifty (n = 150) subjects were randomly assigned to one of three conditions. Subjects were instructed to either fake bad, fake good, or respond honestly, depending on the group to which they were assigned. The study found that type of instruction had a significant effect on all of the subscale scores when the three groups were compared. Individuals in the fake bad condition were able to manipulate scores on each of the four subscales in the predicted direction. No significant differences were found between the fake good and control group scores. Conclusions are drawn regarding the URICA. Reference: Brigham, G. S. (1996). Fakeability of the University of Rhode Island Change Assessment with a substance abuse population. Dissertation Abstracts International: Section B: The Sciences and Engineering, 57(5-B), 3449. (UMI No. AAM9630862) Status:Complete
DEWAYNE SHARKEY v. MOLLY O’TOOLE, M.D. Appeal from the Circuit Court for Davidson County No. 07-C-2143 Amanda McClendon, Judge No. M2009-01112-COA-R3-CV - Filed August 19, 2010 An inmate appeals a summary judgment dismissing his medical malpractice and 42 U.S.C. § 1983 claims against the correctional facility’s psychiatrist. Since the defendant’s doctornegated essential elements
The Abortion Issue: Does the Bible support the right of a woman to choose? It does, but conditions apply. To set the record straight right from the beginning, our Bible tells us that Children are a gift of God. Psalm 127:3 Behold, children are a gift of the Lord; The fruit of the womb is a reward. [ NASB ] As so many do in the case of Christ; they reject the gift of life from God