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

Drug Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003496
• Other study ID #: NIDA/NIH 1RC1DA028467-01
• Secondary ID: 1RC1DA028467-01
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2009
• Est. completion date: July 27, 2011

Study information

• Verified date: February 2022
• Source: Wright State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 27, 2011
• Est. primary completion date: July 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Addiction
• Substance-Related Disorders

Intervention

Behavioral:
• Treatment as Usual (TAU)
Outpatient substance abuse treatment
• 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.

Locations

Country	Name	City	State
United States	Maryhaven	Columbus	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Wright State University	Maryhaven, National Institute on Drug Abuse (NIDA), University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome is weeks of abstinence from the primary drug of dependence.		12 months
Secondary	Secondary outcomes include drug-free days and reduction in HIV risk behaviors.		12 months