Trial Outcomes & Findings for Stimulant Abuser Groups to Engage in 12-Step (NCT NCT00573183)
NCT ID: NCT00573183
Last Updated: 2016-12-05
Results Overview
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
471 participants
Primary outcome timeframe
6 months
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
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.
|
Treatment as Usual
Received standard care provided in intensive outpatient drug treatment program
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
237
|
|
Overall Study
COMPLETED
|
162
|
174
|
|
Overall Study
NOT COMPLETED
|
72
|
63
|
Reasons for withdrawal
| Measure |
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.
|
Treatment as Usual
Received standard care provided in intensive outpatient drug treatment program
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
52
|
50
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Incarceration
|
5
|
8
|
|
Overall Study
Other
|
5
|
2
|
Baseline Characteristics
Stimulant Abuser Groups to Engage in 12-Step
Baseline characteristics by cohort
| Measure |
STAGE-12
n=234 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 in the standard intensive outpatient drug treatment program.
|
Treatment as Usual
n=237 Participants
Received standard care provided in intensive outpatient drug treatment program
|
Total
n=471 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
234 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.24 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
38.45 years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
38.35 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Gender
Female
|
145 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Gender
Male
|
89 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=5 Participants
|
237 participants
n=7 Participants
|
471 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Outcome measures
| Measure |
Treatment as Usual
n=217 Participants
Standard treatment as usual in intensive outpatient substance abuse treatment program
|
STAGE-12
n=204 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.
|
|---|---|---|
|
Days of Stimulant Use
|
2.35 days of stimulant use
Standard Deviation 5.39
|
2.13 days of stimulant use
Standard Deviation 4.32
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
Outcome measures
| Measure |
Treatment as Usual
n=189 Participants
Standard treatment as usual in intensive outpatient substance abuse treatment program
|
STAGE-12
n=206 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.
|
|---|---|---|
|
Attendance at 12-step Meetings
|
12.01 days of attending 12-step meetings
Standard Deviation 9.73
|
10.52 days of attending 12-step meetings
Standard Deviation 9.87
|
Adverse Events
STAGE-12
Serious events: 29 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 23 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STAGE-12
n=234 participants at risk
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.
|
Treatment as Usual
n=237 participants at risk
Standard treatment as usual in intensive outpatient substance abuse treatment program
|
|---|---|---|
|
Cardiac disorders
angina pectoris
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Cardiac disorders
tachycardia
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Gastrointestinal disorders
GI haemorrhage
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Gastrointestinal disorders
pancreatic cyst
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 2 • 6 months
|
|
Infections and infestations
appendicitis
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
catheter site infection
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
cellulitis
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Infections and infestations
gateroenteritis viral
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
hepatitis viral
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
influenza
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Infections and infestations
pelvic inflamatory disease
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
pneumonia
|
0.85%
2/234 • Number of events 3 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
pneumonia bacterial
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Infections and infestations
pyelonephritis
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
sepsis
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Infections and infestations
stitch abscess
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Infections and infestations
viral infection
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Injury, poisoning and procedural complications
intentional overdose
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Investigations
blood glucose increased
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Investigations
blood pressure increased
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Metabolism and nutrition disorders
dehydration
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
rheumatoid arthritis
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Nervous system disorders
coma
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Nervous system disorders
convulsion
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Nervous system disorders
partial seizure
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Nervous system disorders
syncope
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Psychiatric disorders
anxiety
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Psychiatric disorders
depression
|
1.3%
3/234 • Number of events 3 • 6 months
|
0.84%
2/237 • Number of events 2 • 6 months
|
|
Psychiatric disorders
depression suicidal
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Psychiatric disorders
hallucination, auditory
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Psychiatric disorders
hallucination, mixed
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Psychiatric disorders
homicidal ideation
|
0.85%
2/234 • Number of events 2 • 6 months
|
0.00%
0/237 • 6 months
|
|
Psychiatric disorders
suicidal ideation
|
2.6%
6/234 • Number of events 7 • 6 months
|
0.84%
2/237 • Number of events 2 • 6 months
|
|
Psychiatric disorders
suicide attempt
|
1.3%
3/234 • Number of events 4 • 6 months
|
1.3%
3/237 • Number of events 4 • 6 months
|
|
Psychiatric disorders
psychotic disorder
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.85%
2/234 • Number of events 2 • 6 months
|
0.00%
0/237 • 6 months
|
|
Skin and subcutaneous tissue disorders
rash papular
|
0.43%
1/234 • Number of events 1 • 6 months
|
0.00%
0/237 • 6 months
|
|
Vascular disorders
hypertension
|
0.00%
0/234 • 6 months
|
0.84%
2/237 • Number of events 2 • 6 months
|
|
Vascular disorders
thrombosis
|
0.00%
0/234 • 6 months
|
0.42%
1/237 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
STAGE-12
n=234 participants at risk
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.
|
Treatment as Usual
n=237 participants at risk
Standard treatment as usual in intensive outpatient substance abuse treatment program
|
|---|---|---|
|
Infections and infestations
pneumonia
|
3.0%
7/234 • Number of events 8 • 6 months
|
2.5%
6/237 • Number of events 7 • 6 months
|
|
Infections and infestations
nasopharyngitis
|
1.7%
4/234 • Number of events 4 • 6 months
|
3.4%
8/237 • Number of events 9 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.8%
9/234 • Number of events 9 • 6 months
|
2.1%
5/237 • Number of events 5 • 6 months
|
|
Psychiatric disorders
depression
|
3.4%
8/234 • Number of events 8 • 6 months
|
3.4%
8/237 • Number of events 9 • 6 months
|
|
Psychiatric disorders
suicidal ideation
|
4.3%
10/234 • Number of events 11 • 6 months
|
2.1%
5/237 • Number of events 5 • 6 months
|
Additional Information
Dr. Dennis Donovan
Univerity of Washington Alcohol & Drug Abuse Institute
Phone: 206-543-0937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place