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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. Status: Complete
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.


Status: Complete
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.

Status: Complete
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 Status: Complete
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

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