Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II)

NCT ID: NCT00929253

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-04-30

Brief 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.

Detailed 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.

Conditions

Opiate Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer delivered CRA + CM + Suboxone

In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for "homework" worksheets are provided. These participants receive vouchers for providing drug negative urine samples.

Group Type: ACTIVE_COMPARATOR

Suboxone

Intervention Type: DRUG

Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks

CRA

Intervention Type: BEHAVIORAL

Computer-delivered Community Reinforcement Approach

Therapy

Intervention Type: BEHAVIORAL

Therapist-delivered therapy

CM

Intervention Type: BEHAVIORAL

Contingency management (vouchers) for providing a drug negative urine sample.

CM + Suboxone

In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer delivered therapy.

Group Type: ACTIVE_COMPARATOR

Suboxone

Intervention Type: DRUG

Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks

Therapy

Intervention Type: BEHAVIORAL

Therapist-delivered therapy

CM

Intervention Type: BEHAVIORAL

Contingency management (vouchers) for providing a drug negative urine sample.

Interventions

Suboxone

Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks

Intervention Type: DRUG

CRA

Computer-delivered Community Reinforcement Approach

Intervention Type: BEHAVIORAL

Therapy

Therapist-delivered therapy

Intervention Type: BEHAVIORAL

CM

Contingency management (vouchers) for providing a drug negative urine sample.

Intervention Type: BEHAVIORAL

Other Intervention Names

Buprenorphine

Eligibility Criteria

Inclusion Criteria

• 18 years old and older
• history of opioid dependence
• significant current opioid use

Exclusion Criteria

• unstable medical or psychiatric conditions
• pregnancy
• incarceration

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Warren K. Bickel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warren K Bickel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18489017 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18571890 (View on PubMed)

Maricich YA, Bickel WK, Marsch LA, Gatchalian K, Botbyl J, Luderer HF. Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Curr Med Res Opin. 2021 Feb;37(2):167-173. doi: 10.1080/03007995.2020.1846022. Epub 2020 Dec 7.

Reference Type: DERIVED

PMID: 33140994 (View on PubMed)

Christensen DR, Landes RD, Jackson L, Marsch LA, Mancino MJ, Chopra MP, Bickel WK. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014 Dec;82(6):964-72. doi: 10.1037/a0037496. Epub 2014 Aug 4.

Reference Type: DERIVED

PMID: 25090043 (View on PubMed)

Related Links

https://fbri.vtc.vt.edu/people-directory/primary-faculty/bickel.html

Click here to learn more about drug addiction studies at the Fralin Biomedical Research Institute at Virginia Tech Carilion

Other Identifiers

IRB 31695

Identifier Type: -

Identifier Source: org_study_id