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

Sponsor
Wright State University (Other)
Overall Status
Completed
CT.gov ID
NCT01003496
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Maryhaven (Other), University of Arkansas (Other)
204
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2
20.7
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Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Treatment as Usual (TAU)
  • Behavioral: TAU + Long-Term Recovery Management
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Actual Study Start Date :
Nov 5, 2009
Actual Primary Completion Date :
Jul 27, 2011
Actual Study Completion Date :
Jul 27, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The main outcome is weeks of abstinence from the primary drug of dependence. [12 months]

Secondary Outcome Measures

  1. Secondary outcomes include drug-free days and reduction in HIV risk behaviors. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maryhaven Columbus Ohio United States 43207

Sponsors and Collaborators

  • Wright State University
  • National Institute on Drug Abuse (NIDA)
  • Maryhaven
  • University of Arkansas

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wright State University
ClinicalTrials.gov Identifier:
NCT01003496
Other Study ID Numbers:
  • NIDA/NIH 1RC1DA028467-01
  • 1RC1DA028467-01
First Posted:
Oct 28, 2009
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022

Study Results

No Results Posted as of Mar 9, 2022