Substance Use Disorders Clinical Trial
Official title:
Reinforcement of Abstinence and Attendance in Substance Abuse Treatment
Verified date | July 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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. 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. Data collection and analysis has been completed.
Status | Completed |
Enrollment | 183 |
Est. completion date | June 2011 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS | Jackson | Mississippi |
United States | Salem VA Medical Center, Salem, VA | Salem | Virginia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Lash SJ, Burden JL, Parker JD, Stephens RS, Budney AJ, Horner RD, Datta S, Jeffreys AS, Grambow SC. Contracting, prompting and reinforcing substance use disorder continuing care. J Subst Abuse Treat. 2013 Apr;44(4):449-56. doi: 10.1016/j.jsat.2012.09.008. — View Citation
Lash SJ, Timko C, Curran GM, McKay JR, Burden JL. Implementation of evidence-based substance use disorder continuing care interventions. Psychol Addict Behav. 2011 Jun;25(2):238-51. doi: 10.1037/a0022608. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90 | Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point. | Assessed at 12 months | No |
Secondary | Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90 | Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point. | Assessed at 3 and 6 months | No |
Secondary | Days Until First Use of Alcohol or Drugs | Baseline to 12 months | No | |
Secondary | Aftercare Attendance | Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment) | Assessed at 3-, 6-, 9-, and 12-months | No |
Secondary | Self-help Support Group Attendance | Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year | No | |
Secondary | Days of Substance Abuse (Across the Prior 90 Days) | Assessed at Baseline, 3-, 6-, and 12-month follow-up | No | |
Secondary | Rates of Hospitalization (Across the Prior 90 Days) | Number of days hospitalized for any reason per the previous 90 days | Assessed at Baseline, 3-, 6-, and 12-months | No |
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