NCT00573183

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

January 29, 2014

Completed
Last Updated

December 5, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

December 13, 2007

Results QC Date

June 4, 2013

Last Update Submit

October 24, 2016

Conditions

Keywords

Cocaine, methamphetamine, amphetamine, other stimulant drugs

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Attendance at 12-step Meetings

    6 months

Study Arms (2)

STAGE-12

EXPERIMENTAL

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.

Behavioral: STAGE-12

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

STAGE-12BEHAVIORAL

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.

STAGE-12
Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Gateway Community Services

Jacksonville, Florida, 32211, United States

Location

Hina Mauka Kaneohe Rehabilitation Services

Kaneohe, Hawaii, 96744, United States

Location

Maryhaven, Inc.

Columbus, Ohio, 43207, United States

Location

Willamette Family Treatment Services

Eugene, Oregon, 97402, United States

Location

ChangePoint, Inc.

Portland, Oregon, 97233, United States

Location

Addiction Medicine Services (WPIC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Dorchester Alcohol and Drug Commission

Summerville, South Carolina, 29483, United States

Location

Nexus Recovery Center

Dallas, Texas, 75228, United States

Location

Evergreen Manor, Inc.

Everett, Washington, 98134, United States

Location

Recovery Centers of King County

Seattle, Washington, 98122, United States

Location

Related 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 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Dennis Donovan
Organization
Univerity of Washington Alcohol & Drug Abuse Institute

Study Officials

  • Dennis Donovan, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Dennis Daley, Ph.D.

    Western Psychiatric Institute and Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 5, 2016

Results First Posted

January 29, 2014

Record last verified: 2016-10

Locations