Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Drug Addiction
• Intervention / Treatment: Behavioral: Treatment as Usual (TAU); Behavioral: TAU + Long-Term Recovery Management

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Maryhaven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual (TAU)	Behavioral: Treatment as Usual (TAU); Outpatient substance abuse treatment
Experimental: TAU + Long-Term Recovery Management (LTRM)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main outcome is weeks of abstinence from the primary drug of dependence.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcomes include drug-free days and reduction in HIV risk behaviors.	12 months

Collaborators and Investigators

• Sponsor: Wright State University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Arkansas; Maryhaven
• Investigators: Principal Investigator: Robert G Carlson, Ph.D., Wright State University Boonshoft School of Medicine; Study Director: Russel Falck, MA, Wright State University Boonshoft School of Medicine; Study Director: Gregory Brigham, Ph.D., Maryhaven; Study Director: Brenda M Booth, Ph.D., University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2009
• Primary Completion (Actual): July 27, 2011
• Study Completion (Actual): July 27, 2011

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 27, 2009
• First Posted (Estimate): October 28, 2009

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cocaine; heroin; contingency management; crack; non-prescribed opioids; community reinforcement approach; facilitated therapeutic alliance; chronic disease treatment models
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: NIDA/NIH 1RC1DA028467-01; 1RC1DA028467-01 (U.S. NIH Grant/Contract)