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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929253
First Posted: June 29, 2009
Last Update Posted: May 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Warren K. Bickel, Virginia Polytechnic Institute and State University
  Purpose
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.

Condition Intervention
Opiate Addiction Drug: Suboxone Behavioral: CRA Behavioral: Therapy Behavioral: CM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10

Resource links provided by NLM:


Further study details as provided by Warren K. Bickel, Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine for each participant [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Delay discounting measures and other non-normal or ordinal outcomes measures will be compared across treatment groups based on nonparametric rank tests. [ Time Frame: 12 weeks ]

Enrollment: 206
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Suboxone
Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Other Name: Buprenorphine
Behavioral: CRA
Computer-delivered Community Reinforcement Approach
Active Comparator: Therapist delivered CRA + 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 deliver therapy, only therapist delivered therapy.
Drug: Suboxone
Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Other Name: Buprenorphine
Behavioral: Therapy
Therapist-delivered therapy
Behavioral: CM
Contingency management (vouchers) for providing a drug negative urine sample.

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, retention, HIV-risk behavior, and cost-effectiveness. 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. Additionally, opioid-dependent individuals who also use cocaine represent a population of substance abusers at particularly high-risk for HIV infection from both their high level of risky drug-injection and sexual risk behavior. Nevertheless, 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929253


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Warren K Bickel, Ph.D. Virginia Polytechnic Institute and State University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warren K. Bickel, Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT00929253     History of Changes
Other Study ID Numbers: IRB 31695
First Submitted: June 25, 2009
First Posted: June 29, 2009
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Warren K. Bickel, Virginia Polytechnic Institute and State University:
Opioid Dependence
Opiates
Hydrocodone
Oxycodone
Oxycontin
Narcotic Abuse

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists