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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00929253
Other study ID # IRB 31695
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2007
Est. completion date April 2010

Study information

Verified date May 2022
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to examine the effects of combined buprenorphine and voucher incentives to promote abstinence from illicit opiate use, along with or without computer-delivered therapy, during treatment of opioid dependence.


Description:

The Community Reinforcement Approach (CRA) with contingency management (CM) is a widely researched and demonstrably efficacious drug abuse treatment. This treatment is derived from drug self-administration research and a behavioral analysis of drug dependence, where abused drugs are thought to compete successfully with the more delayed pro-social reinforcers because of their relatively more immediate reinforcing effects. The CRA treatment with CM approach takes this theoretical view into account by (1) providing immediate positive reinforcement for abstinence via the voucher reinforcement procedure, and (2) having therapists teach skills and encourage behaviors that help improve employment status, family/social relations and increase recreational activities via the CRA treatment. The incentives for abstinence with the enhancement of non-drug sources of reinforcement are then expected to successfully compete with the reinforcement from drug use. Adoption of CRA with CM may be facilitated if it could be delivered so that it is both less costly and requires less staff time to implement. In our previous trial, we demonstrated that among buprenorphine maintained opioid-dependent persons, computer-delivered CRA with CM (i.e., voucher incentives) was as effective as and less costly than therapist-delivered CRA with CM (i.e., voucher incentives). However, the design of that study did not indicate whether the computer-delivered CRA produced increases in abstinence over that produced by the CM (i.e., voucher incentives) procedures alone. Thus, we believe the contribution of the computerized treatment to therapeutic outcomes should be isolated. In this study, which will include only buprenorphine maintained opioid-dependent participants, we plan to examine whether computer-delivered CRA produces increases in abstinence over that produced by CM (i.e., voucher incentives) procedures alone. Specifically, this trial will compare computer-delivered CRA with vouchers (with minimal therapist involvement) and voucher incentives alone in a randomized parallel groups design. Participants will be assigned randomly to receive one of two treatments: (1) computer-delivered CRA along with voucher incentives (i.e., CM); or (2) voucher incentives (i.e., CM) alone. Outcome measures will include abstinence and retention. We hypothesize that the computer-delivered CRA with CM will be more efficacious than CM. Importantly, in this trial, the treatment interventions will reinforce both cocaine and opioid abstinence. Many opioid-dependent individuals also abuse, or are dependent upon, cocaine and polydrug abuse in this population has been rarely addressed. By targeting both drugs, our understanding of effective ways to address polydrug abuse will be increased. Overall, this research will contribute new empirical information regarding the efficacy of providing CRA with CM. Such information may result in more cost-effective treatment and facilitate its dissemination. This research will further examine the utility of computerizing a substantive portion of substance abuse treatment. Computerization of treatment is a novel approach that may positively impact the future of drug abuse treatment.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old and older - history of opioid dependence - significant current opioid use Exclusion Criteria: - unstable medical or psychiatric conditions - pregnancy - incarceration

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Suboxone
Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Behavioral:
CRA
Computer-delivered Community Reinforcement Approach
Therapy
Therapist-delivered therapy
CM
Contingency management (vouchers) for providing a drug negative urine sample.

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008 Apr;16(2):132-43. doi: 10.1037/1064-1297.16.2.132. — View Citation

Kirshenbaum AP, Olsen DM, Bickel WK. A quantitative review of the ubiquitous relapse curve. J Subst Abuse Treat. 2009 Jan;36(1):8-17. doi: 10.1016/j.jsat.2008.04.001. Epub 2008 Jun 24. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Abstinence Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine 12 weeks
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