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Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)

Primary Purpose

Drug Abuse

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
STAGE-12
Treatment as Usual
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring Cocaine, methamphetamine, amphetamine, other stimulant drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gateway Community Services
  • Hina Mauka Kaneohe Rehabilitation Services
  • Maryhaven, Inc.
  • Willamette Family Treatment Services
  • ChangePoint, Inc.
  • Addiction Medicine Services (WPIC)
  • Dorchester Alcohol and Drug Commission
  • Nexus Recovery Center
  • Evergreen Manor, Inc.
  • Recovery Centers of King County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STAGE-12

Treatment as Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Days of Stimulant Use
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period

Secondary Outcome Measures

Attendance at 12-step Meetings
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period

Full Information

First Posted
December 13, 2007
Last Updated
October 24, 2016
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00573183
Brief Title
Stimulant Abuser Groups to Engage in 12-Step
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Cocaine, methamphetamine, amphetamine, other stimulant drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAGE-12
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components.
Intervention Type
Behavioral
Intervention Name(s)
STAGE-12
Intervention Description
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
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Days of Stimulant Use
Description
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Attendance at 12-step Meetings
Description
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Donovan, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis Daley, Ph.D.
Organizational Affiliation
Western Psychiatric Institute and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Community Services
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32211
Country
United States
Facility Name
Hina Mauka Kaneohe Rehabilitation Services
City
Kaneohe
State/Province
Hawaii
ZIP/Postal Code
96744
Country
United States
Facility Name
Maryhaven, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Willamette Family Treatment Services
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97402
Country
United States
Facility Name
ChangePoint, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97233
Country
United States
Facility Name
Addiction Medicine Services (WPIC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Dorchester Alcohol and Drug Commission
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29483
Country
United States
Facility Name
Nexus Recovery Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75228
Country
United States
Facility Name
Evergreen Manor, Inc.
City
Everett
State/Province
Washington
ZIP/Postal Code
98134
Country
United States
Facility Name
Recovery Centers of King County
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22657748
Citation
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. Erratum In: J Subst Abuse Treat. 2015 Feb;49:71. Kau'ibaumhofer, Nicole [corrected to Kau'i Baumhofer, Nicole].
Results Reference
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