Overview

This trial is active, not recruiting.

Condition drug addiction
Treatments treatment as usual (tau), tau + long-term recovery management
Phase phase 3
Sponsor Wright State University
Collaborator National Institute on Drug Abuse (NIDA)
Start date November 2009
End date July 2011
Trial size 204 participants
Trial identifier NCT01003496, 1RC1DA028467-01, NIDA/NIH 1RC1DA028467-01

Summary

The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
treatment as usual (tau)
Outpatient substance abuse treatment
(Experimental)
tau + long-term recovery management
Long-Term Recovery Management (LTRM) combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. Patients randomly assigned to LTRM will be asked to participate in group sessions each month for 12 months.

Primary Outcomes

Measure
The main outcome is weeks of abstinence from the primary drug of dependence.
time frame: 12 months

Secondary Outcomes

Measure
Secondary outcomes include drug-free days and reduction in HIV risk behaviors.
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: To be eligible for the study, a subject must: - At least 18 years of age - Meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). Persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification - Self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at Maryhaven - Willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions). Exclusion Criteria: - Potential subjects will be excluded if they: 1) present with current suicide risk - Have a current, untreated psychotic disorder - Plan to relocate outside of the area within 12 months - Have been sentenced to incarceration of more than 30 days over the next 6 months - Are alcohol dependent without current dependence on cocaine or opioids.

Additional Information

Official title Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Principal investigator Robert G Carlson, Ph.D.
Description Drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. Despite this, substance abuse treatment has traditionally been based on an acute care model. The field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response. In response to these needs we have developed the Long Term Recovery Management (LTRM) model. LTRM is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. LTRM combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. The LTRM model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Wright State University.