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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03278496
Other study ID # DA13003
Secondary ID
Status Completed
Phase N/A
First received March 28, 2014
Last updated September 7, 2017
Start date April 2001
Est. completion date December 2008

Study information

Verified date September 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. It is meant to provide motivation for continued abstinence while enhancing social stability. In this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. Previous research had shown that RBT produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. The present study compared outcomes for patients (N = 243) randomly assigned to receive abstinence-contingent recovery housing with (full RBT) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full RBT) and without additional counseling and both these treatments were superior to usual care referral. Study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.


Description:

Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing delivered with or without intensive day treatment among individuals exiting residential opioid detoxification.

Design Random assignment to one of three conditions: recovery housing alone (RH), abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT, initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months after treatment enrollment.

Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.

Participants Patients (n = 243) who completed medication-assisted opioid detoxification.

Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.


Recruitment information / eligibility

Status Completed
Enrollment 243
Est. completion date December 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- completes residential detoxification for use of opiates and/or cocaine

- willing to go to outpatient aftercare

- agrees to random assignment; signs informed consent

Exclusion Criteria:

- moving out of town

- primary substance use does not include opiates or cocaine

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Recovery Housing plus Counseling
Participants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities.
Usual Care Referral
Participants are referred to an outpatient program of their choosing with an appointment made for them.
Recovery Housing Only
Participant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling.

Locations

Country Name City State
United States Behavioral Pharmacology Research Unit Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary abstinence from opiates and cocaine Free in the community plus self report of no drug use in past 30 days verified with negative urine screen. 6 months post randomization
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