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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00032981
Other study ID # NIDA-CTN-0004-1
Secondary ID
Status Completed
Phase Phase 3
First received April 5, 2002
Last updated January 11, 2017
Start date May 2001
Est. completion date August 2004

Study information

Verified date April 2010
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the therapeutic usefulness of incorporating Motivational Enhancement Treatment into the standard drug abuse treatment entry process of Community Treatment Programs on improving treatment engagement, retention, and outcome.


Description:

Participants seeking treatment at the participating CTPs will be randomly assigned to either "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization, and patient satisfaction. Process assessments will include measures of the working alliance as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI was implemented. Participating CTPs will implement one of two independent protocols, depending on which is the best suited or feasible for the intake procedures at their clinic. Thus, following an invitation to participate, explanation of the study, and provision of informed consent, patients would complete a brief assessment battery followed by either: 1) Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the program versus 3 individual sessions of MET. or 2) Random assignment to 1 individual standard assessment/evaluation session.


Other known NCT identifiers
  • NCT00016770

Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date August 2004
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

Individuals will be eligible for the protocol who:

- Are seeking outpatient treatment for any substance use disorder

- Are willing to participate in the protocol (e.g., to be randomized to treatment, be contacted for follow-up assessment, to have their sessions audiotaped)

- Are able to understand and provide written informed consent

Exclusion Criteria:

Individuals will be excluded who:

- Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment

- Are seeking detoxification only, methadone maintenance treatment or residential inpatient treatment

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior Therapy


Locations

Country Name City State
United States CT Renaissance, Inc. Norwalk Connecticut
United States Northeast Treatment Center Philadelphia Pennsylvania
United States Rehab After Work Philadelphia Pennsylvania
United States Haight Ashbury Free Clinics San Francisco California
United States LMG Programs, Inc. Stamford Connecticut
United States Tarzana Treatment Center Tarzana California

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug use
Primary Retention
Primary HIV risk behaviors
Primary Psychosocial functioning
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