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

NCT ID: NCT01003496

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-05
• Study Completion Date: 2011-07-27

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.

Conditions

Drug Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as Usual (TAU)

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Outpatient substance abuse treatment

TAU + Long-Term Recovery Management (LTRM)

Group Type: EXPERIMENTAL

TAU + Long-Term Recovery Management

Intervention Type: BEHAVIORAL

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.

Interventions

Treatment as Usual (TAU)

Outpatient substance abuse treatment

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Maryhaven

UNKNOWN

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Wright State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Carlson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wright State University Boonshoft School of Medicine

Russel Falck, MA

Role: STUDY_DIRECTOR

Wright State University Boonshoft School of Medicine

Gregory Brigham, Ph.D.

Role: STUDY_DIRECTOR

Maryhaven

Brenda M Booth, Ph.D.

Role: STUDY_DIRECTOR

University of Arkansas

Locations

Maryhaven

Columbus, Ohio, United States

Countries

United States

Other Identifiers

1RC1DA028467-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA/NIH 1RC1DA028467-01

Identifier Type: -

Identifier Source: org_study_id