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Reinforcement of Abstinence and Continuing Care in Substance Abuse Treatment
This study is ongoing, but not recruiting participants.
First Received: February 6, 2006   Last Updated: February 9, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288886
  Purpose

The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Participants are primarily Caucasian (44%) and African-American (55%), predominately male (96%) veterans. Co-morbid psychiatric disorders are present in 62% of the sample and 33% are alcohol dependent, while 68% are drug dependent (with or without alcohol dependence). Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care.

Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels. The current study will seek to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome.

Dissemination and implementation efforts will be ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC.


Condition Intervention Phase
Substance Use Disorders
Alcohol Abuse
Alcoholism
Substance Dependence
Substance Abuse
Behavioral: Contracting, Prompting & Reinforcing Abstinence & Attendance
Phase II

MedlinePlus related topics: Alcoholism Ataxia Telangiectasia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title: Reinforcement of Abstinence and Attendance in Substance Abuse Treatment

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Abstinence from substance use at 1 year (for at least 90 days). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization frequency at 1 year; % days using substances at 1 year; days until the participants final aftercare session; days until the participants final AA/NA session; whether participants complete the first 3 months of treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: March 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Contracting, Prompting & Reinforcing Abstinence & Attendance
Contingent reinforcement of abstinence and prompting of AA/NA attendance

Detailed Description:

The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. Among CPR participants, 55% met the VA's SUD continuity of care performance measure (attending at least 2 therapy sessions each month for 3 months), compared to 36% of those in standard treatment (STX). On the primary outcome variable, 57% of the participants in the CPR condition were abstinent at the 1-year follow-up compared to 37% of those in STX. Post hoc moderator analyses also indicate that the intervention was particularly effective for participants with co-morbid psychiatric disorders. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site randomized clinical trial to examine the effectiveness of CPR+ with 2 specific goals: 1) to compare CPR+ to STX on adherence to continuing care (i.e., AA/NA participation and aftercare therapy) and 2) to assess its effect on treatment outcome. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Participants are primarily Caucasian (44%) and African-American (55%), predominately male (96%) veterans. Co-morbid psychiatric disorders are present in 62% of the sample and 33% are alcohol dependent, while 67% are drug dependent (with or without alcohol dependence). Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels using the Form-90 Interview, the Addiction Severity Index (ASI), questionnaire responses, and substance use screens. Treatment adherence will be measured using VA databases, medical records, therapist ratings, and questionnaire responses. Abstinence rates will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations. Secondary outcomes will be analyzed using both marginal and linear mixed-effects models as appropriate. The current study will seek to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts will be ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants were recruited from consecutive veterans who successful complete the 28-day SARRTP at the Salem VAMC and the 21-day SARRTP at the Jackson VAMC. Participants who are uninterested in aftercare, who have unstable housing or other factors that made aftercare participation difficult, will be included to maximize the generalizability of our results.

Exclusion Criteria:

Individuals who did not live within a 60-minute drive, and those who did not have transportation and a work schedule allowing attendance of aftercare were ineligible.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288886

Locations
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center
Jackson, Mississippi, United States, 39216
United States, Virginia
VA Medical Center
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Investigators
Principal Investigator: Steven J. Lash, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Lash, Steven - Principal Investigator )
Study ID Numbers: IIR 03-267
Study First Received: February 6, 2006
Last Updated: February 9, 2009
ClinicalTrials.gov Identifier: NCT00288886     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Compliance
Aftercare
Reinforcement, social
Alcoholics Anonymous
Support Groups
Treatment Outcome

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

Additional relevant MeSH terms:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 07, 2009