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| ID | Type | Description | Link |
|---|---|---|---|
| U10DA013714 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as Usual | Active Comparator | Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAGE-12 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Donovan, Ph.D. | University of Washington | Principal Investigator |
| Dennis Daley, Ph.D. | Western Psychiatric Institute and Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Community Services | Jacksonville | Florida | 32211 | United States | ||
| Hina Mauka Kaneohe Rehabilitation Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22657748 | Result | 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. |
| Label | URL |
|---|---|
| Link to description of the STAGE-12 protocol on the NIDA Clinical Trials Network web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | STAGE-12 | Received 3 individual and 5 group 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. |
| FG001 | Treatment as Usual | Received standard care provided in intensive outpatient drug treatment program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | STAGE-12 | Received 3 individual and 5 group 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days of Stimulant Use | Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period | The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes. | Posted | Mean | Standard Deviation | days of stimulant use | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STAGE-12 | Received 3 individual and 5 group 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| angina pectoris | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Donovan | Univerity of Washington Alcohol & Drug Abuse Institute | 206-543-0937 | ddonovan@u.washington.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as Usual | Behavioral |
|
| Kaneohe |
| Hawaii |
| 96744 |
| United States |
| Maryhaven, Inc. | Columbus | Ohio | 43207 | United States |
| Willamette Family Treatment Services | Eugene | Oregon | 97402 | United States |
| ChangePoint, Inc. | Portland | Oregon | 97233 | United States |
| Addiction Medicine Services (WPIC) | Pittsburgh | Pennsylvania | 15213 | United States |
| Dorchester Alcohol and Drug Commission | Summerville | South Carolina | 29483 | United States |
| Nexus Recovery Center | Dallas | Texas | 75228 | United States |
| Evergreen Manor, Inc. | Everett | Washington | 98134 | United States |
| Recovery Centers of King County | Seattle | Washington | 98122 | United States |
| Death |
|
| Adverse Event |
|
| Incarceration |
|
| Other |
|
| Treatment as Usual |
Received standard care provided in intensive outpatient drug treatment program |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Received 3 individual and 5 group 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.
|
|
|
| Secondary | Attendance at 12-step Meetings | Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period | The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values | Posted | Mean | Standard Deviation | days of attending 12-step meetings | 6 months |
|
|
|
|
| 29 |
| 234 |
| 10 |
| 234 |
| EG001 | Treatment as Usual | Standard treatment as usual in intensive outpatient substance abuse treatment program | 23 | 237 | 15 | 237 |
| tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| GI haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| pancreatic cyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| appendicitis | Infections and infestations | Non-systematic Assessment |
|
| catheter site infection | Infections and infestations | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | Non-systematic Assessment |
|
| gateroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| hepatitis viral | Infections and infestations | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
| pelvic inflamatory disease | Infections and infestations | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | Non-systematic Assessment |
|
| pneumonia bacterial | Infections and infestations | Non-systematic Assessment |
|
| pyelonephritis | Infections and infestations | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| stitch abscess | Infections and infestations | Non-systematic Assessment |
|
| viral infection | Infections and infestations | Non-systematic Assessment |
|
| accidental overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| intentional overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| blood glucose increased | Investigations | Non-systematic Assessment |
|
| blood pressure increased | Investigations | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| coma | Nervous system disorders | Non-systematic Assessment |
|
| convulsion | Nervous system disorders | Non-systematic Assessment |
|
| partial seizure | Nervous system disorders | Non-systematic Assessment |
|
| syncope | Nervous system disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| depression suicidal | Psychiatric disorders | Non-systematic Assessment |
|
| hallucination, auditory | Psychiatric disorders | Systematic Assessment |
|
| hallucination, mixed | Psychiatric disorders | Non-systematic Assessment |
|
| homicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| rash papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| thrombosis | Vascular disorders | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
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