Trial Outcomes & Findings for Optimizing Pharmacotherapy for Bipolar Alcoholics (NCT NCT00302133)
NCT ID: NCT00302133
Last Updated: 2016-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-05-17
Participant Flow
Sample drawn from University-based mental health services, community treatment programs and advertisement
Total telephone screened included 696 inquiries: 517 excluded for not meeting initial screen criteria; 91 excluded for lost to follow-up with continuing screening; 88 enrolled into the study. Of the 88 enrolled, 35 excluded for not meeting the inclusion criteria; 35 were lost to follow-up before group assignment.
Participant milestones
| Measure |
Naltrexone
Naltrexone add on to valproate open label
Naltrexone Hydrochloride 50 mg daily for 12 weeks
|
Placebo
Placebo add on to valproate open label
Placebo one capsule daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Pharmacotherapy for Bipolar Alcoholics
Baseline characteristics by cohort
| Measure |
Naltrexone
n=9 Participants
Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate
|
Placebo
n=9 Participants
Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.
Outcome measures
| Measure |
Naltrexone
n=8 Participants
Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate
|
Placebo
n=8 Participants
Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks
|
|---|---|---|
|
Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
|
0.6 standard drinks/drinking day
Standard Deviation 1.8
|
3.8 standard drinks/drinking day
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 12 weeksProportion of subjects abstinent during the last 4 weeks of the trial
Outcome measures
| Measure |
Naltrexone
n=9 Participants
Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate
|
Placebo
n=9 Participants
Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks
|
|---|---|---|
|
% Subjects Abstinent
|
66 percentage of participants
|
33 percentage of participants
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=9 participants at risk
Naltrexone add on to valproate open label
naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate
|
Placebo
n=9 participants at risk
Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • Adverse events reported by subjects during their participation in the study
|
33.3%
3/9 • Number of events 3 • Adverse events reported by subjects during their participation in the study
|
|
Cardiac disorders
Palpitation
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
33.3%
3/9 • Number of events 3 • Adverse events reported by subjects during their participation in the study
|
|
Gastrointestinal disorders
Nausea/ diarrhea
|
22.2%
2/9 • Number of events 2 • Adverse events reported by subjects during their participation in the study
|
11.1%
1/9 • Number of events 1 • Adverse events reported by subjects during their participation in the study
|
|
Reproductive system and breast disorders
Abdominal cramps
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
11.1%
1/9 • Number of events 1 • Adverse events reported by subjects during their participation in the study
|
|
Musculoskeletal and connective tissue disorders
back pain
|
11.1%
1/9 • Number of events 1 • Adverse events reported by subjects during their participation in the study
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
11.1%
1/9 • Number of events 1 • Adverse events reported by subjects during their participation in the study
|
|
Nervous system disorders
Insomnia
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
22.2%
2/9 • Number of events 2 • Adverse events reported by subjects during their participation in the study
|
|
Injury, poisoning and procedural complications
Accident
|
11.1%
1/9 • Number of events 1 • Adverse events reported by subjects during their participation in the study
|
0.00%
0/9 • Adverse events reported by subjects during their participation in the study
|
Additional Information
Ihsan Salloum, MD, MPH
University of Miami Miller School of Medicine
Phone: 305 243-7931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place