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

NCT01003496 | Completed Phase 3

• 2 other identifiers: NIDA/NIH 1RC1DA028467-011RC1DA028467-01
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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).

Conditions

Drug Addiction

Keywords

Cocaine; crack; heroin; non-prescribed opioids; contingency management; community reinforcement approach; facilitated therapeutic alliance; chronic disease treatment models

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Behavioral: Treatment as Usual (TAU)

TAU + Long-Term Recovery Management (LTRM)

EXPERIMENTAL

Behavioral: TAU + Long-Term Recovery Management

Interventions

Treatment as Usual (TAU) BEHAVIORAL

Outpatient substance abuse treatment

Treatment as Usual (TAU)

TAU + Long-Term Recovery Management 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.

TAU + Long-Term Recovery Management (LTRM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Maryhaven

Columbus, Ohio, 43207, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert G Carlson, Ph.D.

  Wright State University Boonshoft School of Medicine

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: November 5, 2009
• Primary Completion: July 27, 2011
• Study Completion: July 27, 2011
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

US (1)