Stimulant Abuser Groups to Engage in 12-Step

NCT ID: NCT00573183

Last Updated: 2016-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to determine whether a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes.

Detailed Description

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This protocol is to evaluate the degree to which a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant abusers. The primary objective is to evaluate reduction in percent of days of stimulant use as measured by self-report. Secondary objectives include evaluating reduction in percent days of use of other substances, the degree to which STAGE-12 increases involvement in 12-step activities and attendance at 12-step meetings, and the extent to which such 12 -step involvement and meeting attendance mediate substance use outcomes.

Conditions

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Drug Abuse

Keywords

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Cocaine, methamphetamine, amphetamine, other stimulant drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STAGE-12

STAGE-12 received 3 individual and 5 group 12-step facilitation sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program and were integrated into treatment as usual.

Group Type EXPERIMENTAL

STAGE-12

Intervention Type BEHAVIORAL

The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.

Treatment as Usual

Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Interventions

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STAGE-12

The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.

Intervention Type BEHAVIORAL

Treatment as Usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* seeking outpatient treatment for stimulant abuse or dependence
* current diagnosis of stimulant abuse or dependence
* willing to participate in the protocol

Exclusion Criteria

* not sufficiently medically or psychiatrically stable
* pending legal action that would inhibit their participation in the study
* in need of detoxification from opiates
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Dennis Donovan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Donovan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Dennis Daley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Western Psychiatric Institute and Clinic

Locations

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Gateway Community Services

Jacksonville, Florida, United States

Site Status

Hina Mauka Kaneohe Rehabilitation Services

Kaneohe, Hawaii, United States

Site Status

Maryhaven, Inc.

Columbus, Ohio, United States

Site Status

Willamette Family Treatment Services

Eugene, Oregon, United States

Site Status

ChangePoint, Inc.

Portland, Oregon, United States

Site Status

Addiction Medicine Services (WPIC)

Pittsburgh, Pennsylvania, United States

Site Status

Dorchester Alcohol and Drug Commission

Summerville, South Carolina, United States

Site Status

Nexus Recovery Center

Dallas, Texas, United States

Site Status

Evergreen Manor, Inc.

Everett, Washington, United States

Site Status

Recovery Centers of King County

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Donovan DM, Daley DC, Brigham GS, Hodgkins CC, Perl HI, Garrett SB, Doyle SR, Floyd AS, Knox PC, Botero C, Kelly TM, Killeen TK, Hayes C, Kau'i Baumhofer N, Seamans C, Zammarelli L. Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network. J Subst Abuse Treat. 2013 Jan;44(1):103-14. doi: 10.1016/j.jsat.2012.04.004. Epub 2012 May 31.

Reference Type RESULT
PMID: 22657748 (View on PubMed)

Related Links

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Other Identifiers

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U10DA013714

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-CTN-0031

Identifier Type: -

Identifier Source: org_study_id