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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warren K. Bickel, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT00929253
First received: June 25, 2009
Last updated: June 11, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Computer Delivered CRA (Bup II)

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 therapy with CM
In this arm of the study, therapy is delivered by a computer. Fluency training is provided for each participant. 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: CM with therapist delivered therapy
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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, NIDA 5 RO1 DA012997-10
Study First Received: June 25, 2009
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Polytechnic Institute and State University:
Opioid Dependence
Opiates
Hydrocodone
Oxycodone
Oxycontin
Narcotic Abuse

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014