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

Primary Purpose

Drug Addiction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Treatment as Usual (TAU)
TAU + Long-Term Recovery Management
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Addiction focused on measuring Cocaine, crack, heroin, non-prescribed opioids, contingency management, community reinforcement approach, facilitated therapeutic alliance, chronic disease treatment models

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maryhaven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual (TAU)

TAU + Long-Term Recovery Management (LTRM)

Arm Description

Outcomes

Primary Outcome Measures

The main outcome is weeks of abstinence from the primary drug of dependence.

Secondary Outcome Measures

Secondary outcomes include drug-free days and reduction in HIV risk behaviors.

Full Information

First Posted
October 27, 2009
Last Updated
February 21, 2022
Sponsor
Wright State University
Collaborators
National Institute on Drug Abuse (NIDA), Maryhaven, University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT01003496
Brief Title
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Official Title
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2009 (Actual)
Primary Completion Date
July 27, 2011 (Actual)
Study Completion Date
July 27, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University
Collaborators
National Institute on Drug Abuse (NIDA), Maryhaven, University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
Keywords
Cocaine, crack, heroin, non-prescribed opioids, contingency management, community reinforcement approach, facilitated therapeutic alliance, chronic disease treatment models

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Title
TAU + Long-Term Recovery Management (LTRM)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Outpatient substance abuse treatment
Intervention Type
Behavioral
Intervention Name(s)
TAU + Long-Term Recovery Management
Intervention Description
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 Outcome Measure Information:
Title
The main outcome is weeks of abstinence from the primary drug of dependence.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary outcomes include drug-free days and reduction in HIV risk behaviors.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Carlson, Ph.D.
Organizational Affiliation
Wright State University Boonshoft School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russel Falck, MA
Organizational Affiliation
Wright State University Boonshoft School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gregory Brigham, Ph.D.
Organizational Affiliation
Maryhaven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brenda M Booth, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Study Director
Facility Information:
Facility Name
Maryhaven
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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