- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929253
Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II) (CAT)
Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Other Names:
Computer-delivered Community Reinforcement Approach
Therapist-delivered therapy
Contingency management (vouchers) for providing a drug negative urine sample.
|
Active Comparator: 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.
|
Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Other Names:
Therapist-delivered therapy
Contingency management (vouchers) for providing a drug negative urine sample.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abstinence
Time Frame: 12 weeks
|
Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Warren K Bickel, Ph.D., Virginia Polytechnic Institute and State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- IRB 31695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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