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

NCT00929253 | Completed Results DMC

• 1 other identifier: IRB 31695
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Addiction

Keywords

Opioid Dependence; Opiates; Hydrocodone; Oxycodone; Oxycontin; Narcotic Abuse

Outcome Measures

Primary Outcomes (1)

• Abstinence

  Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine

  12 weeks

Study Arms (2)

Computer delivered CRA + CM + Suboxone

ACTIVE COMPARATOR

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; Behavioral: CRA; Behavioral: Therapy; Behavioral: CM

CM + Suboxone

ACTIVE COMPARATOR

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.

Drug: Suboxone; Behavioral: Therapy; Behavioral: CM

Interventions

Suboxone DRUG

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

Also known as: Buprenorphine

CM + Suboxone; Computer delivered CRA + CM + Suboxone

CRA BEHAVIORAL

Computer-delivered Community Reinforcement Approach

Computer delivered CRA + CM + Suboxone

Therapy BEHAVIORAL

Therapist-delivered therapy

CM + Suboxone; Computer delivered CRA + CM + Suboxone

CM BEHAVIORAL

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

CM + Suboxone; Computer delivered CRA + CM + Suboxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unstable medical or psychiatric conditions
• pregnancy
• incarceration

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (4)

• 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.

  PMID: 18489017 RESULT

• 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.

  PMID: 18571890 RESULT

• 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.

  PMID: 33140994 DERIVED

• 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.

  PMID: 25090043 DERIVED

Related Links

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

MeSH Terms

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine; Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Warren K. Bickel
• Organization: Virginia Tech

wkbickel@vt.edu

540-526-2015

Study Officials

• Warren K Bickel, Ph.D.

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: September 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 27, 2022
• Results First Posted: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)