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

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ClinicalTrials.gov Identifier: NCT00573183
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : January 29, 2014
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dennis Donovan, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Drug Abuse
Interventions Behavioral: STAGE-12
Behavioral: Treatment as Usual
Enrollment 471
Recruitment Details  
Pre-assignment Details  
Arm/Group Title STAGE-12 Treatment as Usual
Hide Arm/Group Description 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. Received standard care provided in intensive outpatient drug treatment program
Period Title: Overall Study
Started 234 237
Completed 162 174
Not Completed 72 63
Reason Not Completed
Lost to Follow-up             52             50
Withdrawal by Subject             8             2
Death             0             1
Adverse Event             2             0
Incarceration             5             8
Other             5             2
Arm/Group Title STAGE-12 Treatment as Usual Total
Hide Arm/Group Description 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. Received standard care provided in intensive outpatient drug treatment program Total of all reporting groups
Overall Number of Baseline Participants 234 237 471
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 237 participants 471 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
234
 100.0%
237
 100.0%
471
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 237 participants 471 participants
38.24  (10.04) 38.45  (9.40) 38.35  (9.71)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 237 participants 471 participants
Female
145
  62.0%
132
  55.7%
277
  58.8%
Male
89
  38.0%
105
  44.3%
194
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 234 participants 237 participants 471 participants
234 237 471
1.Primary Outcome
Title Days of Stimulant Use
Hide Description Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment as Usual STAGE-12
Hide Arm/Group Description:
Standard treatment as usual in intensive outpatient substance abuse treatment program
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.
Overall Number of Participants Analyzed 217 204
Mean (Standard Deviation)
Unit of Measure: days of stimulant use
2.35  (5.39) 2.13  (4.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment as Usual, STAGE-12
Comments Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 95% confidence interval
Method Mixed Models Analysis
Comments A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.3404
Confidence Interval (2-Sided) 95%
1.2019 to 9.2842
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4134
Estimation Comments The STAGE-12 group represented the numerator and TAU represented the reference group/denominator
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment as Usual, STAGE-12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.4373
Confidence Interval (2-Sided) 95%
1.0131 to 5.8637
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4134
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Attendance at 12-step Meetings
Hide Description Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title STAGE-12 Treatment as Usual
Hide Arm/Group Description:
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.
Standard treatment as usual in intensive outpatient substance abuse treatment program
Overall Number of Participants Analyzed 189 206
Mean (Standard Deviation)
Unit of Measure: days of attending 12-step meetings
12.01  (9.73) 10.52  (9.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STAGE-12, Treatment as Usual
Comments Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Statistical Model - zero-inflated negative binomial random-effects regression
Method Zero-inflated negative binomial random-e
Comments Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title STAGE-12 Treatment as Usual
Hide Arm/Group Description 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. Standard treatment as usual in intensive outpatient substance abuse treatment program
All-Cause Mortality
STAGE-12 Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
STAGE-12 Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/234 (12.39%)      23/237 (9.70%)    
Cardiac disorders     
angina pectoris *  1/234 (0.43%)  1 1/237 (0.42%)  1
tachycardia *  1/234 (0.43%)  1 0/237 (0.00%)  0
Gastrointestinal disorders     
GI haemorrhage *  1/234 (0.43%)  1 0/237 (0.00%)  0
pancreatic cyst *  1/234 (0.43%)  1 0/237 (0.00%)  0
pancreatitis *  0/234 (0.00%)  0 1/237 (0.42%)  2
Infections and infestations     
appendicitis *  0/234 (0.00%)  0 1/237 (0.42%)  1
catheter site infection *  0/234 (0.00%)  0 1/237 (0.42%)  1
cellulitis *  1/234 (0.43%)  1 0/237 (0.00%)  0
gateroenteritis viral *  0/234 (0.00%)  0 1/237 (0.42%)  1
hepatitis viral *  0/234 (0.00%)  0 1/237 (0.42%)  1
influenza *  1/234 (0.43%)  1 0/237 (0.00%)  0
pelvic inflamatory disease *  0/234 (0.00%)  0 1/237 (0.42%)  1
pneumonia *  2/234 (0.85%)  3 1/237 (0.42%)  1
pneumonia bacterial *  1/234 (0.43%)  1 0/237 (0.00%)  0
pyelonephritis *  0/234 (0.00%)  0 1/237 (0.42%)  1
sepsis   1/234 (0.43%)  1 0/237 (0.00%)  0
stitch abscess *  0/234 (0.00%)  0 1/237 (0.42%)  1
viral infection *  1/234 (0.43%)  1 0/237 (0.00%)  0
Injury, poisoning and procedural complications     
accidental overdose *  1/234 (0.43%)  1 0/237 (0.00%)  0
ankle fracture *  1/234 (0.43%)  1 0/237 (0.00%)  0
intentional overdose *  1/234 (0.43%)  1 0/237 (0.00%)  0
subdural haematoma *  0/234 (0.00%)  0 1/237 (0.42%)  1
Investigations     
blood glucose increased *  1/234 (0.43%)  1 1/237 (0.42%)  1
blood pressure increased *  1/234 (0.43%)  1 0/237 (0.00%)  0
Metabolism and nutrition disorders     
dehydration *  1/234 (0.43%)  1 0/237 (0.00%)  0
diabetes mellitus *  0/234 (0.00%)  0 1/237 (0.42%)  1
hypoglycemia *  1/234 (0.43%)  1 1/237 (0.42%)  1
Musculoskeletal and connective tissue disorders     
back pain *  0/234 (0.00%)  0 1/237 (0.42%)  1
rheumatoid arthritis *  0/234 (0.00%)  0 1/237 (0.42%)  1
Nervous system disorders     
coma *  1/234 (0.43%)  1 0/237 (0.00%)  0
convulsion *  0/234 (0.00%)  0 1/237 (0.42%)  1
partial seizure *  1/234 (0.43%)  1 0/237 (0.00%)  0
syncope *  0/234 (0.00%)  0 1/237 (0.42%)  1
Psychiatric disorders     
anxiety *  0/234 (0.00%)  0 1/237 (0.42%)  1
depression *  3/234 (1.28%)  3 2/237 (0.84%)  2
depression suicidal *  1/234 (0.43%)  1 1/237 (0.42%)  1
hallucination, auditory   0/234 (0.00%)  0 1/237 (0.42%)  1
hallucination, mixed *  0/234 (0.00%)  0 1/237 (0.42%)  1
homicidal ideation *  2/234 (0.85%)  2 0/237 (0.00%)  0
suicidal ideation *  6/234 (2.56%)  7 2/237 (0.84%)  2
suicide attempt *  3/234 (1.28%)  4 3/237 (1.27%)  4
psychotic disorder *  0/234 (0.00%)  0 1/237 (0.42%)  1
Respiratory, thoracic and mediastinal disorders     
asthma *  2/234 (0.85%)  2 0/237 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash papular *  1/234 (0.43%)  1 0/237 (0.00%)  0
Vascular disorders     
hypertension *  0/234 (0.00%)  0 2/237 (0.84%)  2
thrombosis *  0/234 (0.00%)  0 1/237 (0.42%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
STAGE-12 Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/234 (4.27%)      15/237 (6.33%)    
Infections and infestations     
pneumonia *  7/234 (2.99%)  8 6/237 (2.53%)  7
nasopharyngitis *  4/234 (1.71%)  4 8/237 (3.38%)  9
Musculoskeletal and connective tissue disorders     
back pain *  9/234 (3.85%)  9 5/237 (2.11%)  5
Psychiatric disorders     
depression *  8/234 (3.42%)  8 8/237 (3.38%)  9
suicidal ideation *  10/234 (4.27%)  11 5/237 (2.11%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dennis Donovan
Organization: Univerity of Washington Alcohol & Drug Abuse Institute
Phone: 206-543-0937
EMail: ddonovan@u.washington.edu
Layout table for additonal information
Responsible Party: Dennis Donovan, University of Washington
ClinicalTrials.gov Identifier: NCT00573183    
Other Study ID Numbers: NIDA-CTN-0031
U10DA013714 ( U.S. NIH Grant/Contract )
First Submitted: December 13, 2007
First Posted: December 14, 2007
Results First Submitted: June 4, 2013
Results First Posted: January 29, 2014
Last Update Posted: December 5, 2016