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

Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929253
Acronym
CAT
Enrollment
170
Registered
2009-06-29
Start date
2007-09-30
Completion date
2010-04-30
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Addiction

Keywords

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

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.

Interventions

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

BEHAVIORALCRA

Computer-delivered Community Reinforcement Approach

BEHAVIORALTherapy

Therapist-delivered therapy

BEHAVIORALCM

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

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* unstable medical or psychiatric conditions * pregnancy * incarceration

Design outcomes

Primary

MeasureTime frameDescription
Abstinence12 weeksAbstinence defined as the longest documented period of continuous abstinence from opioids and cocaine

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks CRA: Computer-delivered Community Reinforcement Approach
91
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 treatment as usual consisting of biweekly 30-minute counseling sessions. Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks Therapy: treatment as usual CM: Contingency management (vouchers) for providing a drug negative urine sample.
79
Total170

Baseline characteristics

CharacteristicComputer Delivered CRA + CM + SuboxoneTotalCM + Suboxone
Age, Continuous32.2 years
STANDARD_DEVIATION 9.85
32.9 years
STANDARD_DEVIATION 9.82
33.6 years
STANDARD_DEVIATION 9.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
91 Participants170 Participants79 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants6 Participants4 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
87 Participants162 Participants75 Participants
Region of Enrollment
United States
91 participants170 participants79 participants
Sex: Female, Male
Female
46 Participants78 Participants32 Participants
Sex: Female, Male
Male
45 Participants92 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
57 / 9155 / 79
serious
Total, serious adverse events
0 / 910 / 79

Outcome results

Primary

Abstinence

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

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Computer Delivered CRA + CM + SuboxoneAbstinence55.0 daysStandard Deviation 26.2
CM + SuboxoneAbstinence49.5 daysStandard Deviation 30.6

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026