Stimulant Abuser Groups to Engage in 12-Step

Drug Abuse Clinical Trial

— STAGE-12  

Official title:

Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by Increasing 12-Step Involvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573183
• Other study ID #: NIDA-CTN-0031
• Secondary ID: U10DA013714
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2007
• Last updated: January 28, 2014
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: University of Washington
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Abuse

Intervention

Behavioral:
• 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.
• Treatment as Usual

Locations

Country	Name	City	State
United States	Maryhaven, Inc.	Columbus	Ohio
United States	Nexus Recovery Center	Dallas	Texas
United States	Willamette Family Treatment Services	Eugene	Oregon
United States	Evergreen Manor, Inc.	Everett	Washington
United States	Gateway Community Services	Jacksonville	Florida
United States	Hina Mauka Kaneohe Rehabilitation Services	Kaneohe	Hawaii
United States	Addiction Medicine Services (WPIC)	Pittsburgh	Pennsylvania
United States	ChangePoint, Inc.	Portland	Oregon
United States	Recovery Centers of King County	Seattle	Washington
United States	Dorchester Alcohol and Drug Commission	Summerville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Na — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of Stimulant Use	Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period	6 months	No
Secondary	Attendance at 12-step Meetings	Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period	6 months	No

External Links

•   Link to description of the STAGE-12 protocol on the NIDA Clinical Trials Network web site