Trial Outcomes & Findings for Acamprosate vs. Placebo in Bipolar Alcoholics (NCT NCT00466661)

NCT ID: NCT00466661

Last Updated: 2018-12-14

Results Overview

Number of days after randomization until consumption of first alcoholic beverage per self-report.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-12-14

Participant Flow

Recruitment by clinical referral

Two week lead-in (Screening, Baseline)

Participant milestones

Measure	Acamprosate 666 mg p.o. TID	Placebo Matching placebo
Overall Study STARTED	16	17
Overall Study At Least 1 Postrandomization Visit	14	16
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acamprosate vs. Placebo in Bipolar Alcoholics

Baseline characteristics by cohort

Measure	Acamprosate n=16 Participants 666 mg p.o. TID	Placebo n=17 Participants Matching placebo	Total n=33 Participants Total of all reporting groups
Age, Continuous	40.8 years STANDARD_DEVIATION 6.7 • n=5 Participants	43.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	42.1 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Number of days after randomization until consumption of first alcoholic beverage per self-report.

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Time to First Drink (Days)	16.5 Days Interval 6.0 to The upper range of the confidence interval was calculated to be infinity	8.0 Days Interval 2.0 to The upper range of the confidence interval was calculated to be infinity

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Percentage of days in trial with no alcohol consumption

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Percent Days Abstinent	77.0 percentage of days in trial Standard Deviation 28.2	73.0 percentage of days in trial Standard Deviation 29.5

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Percent Heavy Drinking Days	6.4 percentage of days drinking Standard Deviation 8.4	10.7 percentage of days drinking Standard Deviation 14.6

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Measured level of validated serum alcohol biomarker

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Percent Carbohydrate-deficient Transferrin	2.4 "percent CDT" Standard Deviation 0.8	2.5 "percent CDT" Standard Deviation 1.8

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Measured levels of validated serum alcohol biomarker

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Gamma-glutamyltransferase	37.1 Gamma-glutamyltransferase U/L Standard Deviation 40.0	63.8 Gamma-glutamyltransferase U/L Standard Deviation 67.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Higher scores indicate worse outcome; minimum score = 0, maximum score = 40

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Obsessive Compulsive Drinking Scale Score	10.8 score on a scale Standard Deviation 9.5	15.3 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Montgomery Asberg Depression Rating Scale Score	8.7 score on a scale Standard Deviation 6.5	11.3 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Young Mania Rating Scale Score	5.3 score on a scale Standard Deviation 2.9	5.4 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 8 weeks

Population: Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).

Higher values indicate worse outcomes; minimum value = 1, maximum value = 7

Outcome measures

Measure	Acamprosate n=14 Participants Participants assigned to acamprosate with at least one return visit after randomization	Placebo n=16 Participants Participants assigned to placebo who returned for at least one visit after randomization
Clinical Global Impression Scale Score	2.7 score on a scale Standard Deviation 1.4	3.7 score on a scale Standard Deviation 1.1

Adverse Events

Acamprosate

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acamprosate n=14 participants at risk Participants assigned to acamprosate	Placebo n=16 participants at risk Participants assigned to placebo
Psychiatric disorders Hospitalization	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	12.5% 2/16 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Nervous system disorders Seizure	0.00% 0/14 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	6.2% 1/16 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Skin and subcutaneous tissue disorders Anaphylactoid skin reaction	7.1% 1/14 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	0.00% 0/16 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).

Other adverse events

Measure	Acamprosate n=14 participants at risk Participants assigned to acamprosate	Placebo n=16 participants at risk Participants assigned to placebo
Gastrointestinal disorders Nausea	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	25.0% 4/16 • Number of events 4 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	18.8% 3/16 • Number of events 3 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Gastrointestinal disorders Vomiting	0.00% 0/14 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	18.8% 3/16 • Number of events 3 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
General disorders Headache	7.1% 1/14 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	12.5% 2/16 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Gastrointestinal disorders Dyspepsia	7.1% 1/14 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	12.5% 2/16 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
General disorders Diffuse aches	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	6.2% 1/16 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	12.5% 2/16 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Psychiatric disorders Suicidal ideation	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	6.2% 1/16 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Nervous system disorders Tremor	14.3% 2/14 • Number of events 2 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	0.00% 0/16 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).	6.2% 1/16 • Number of events 1 • 8 weeks Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).

Additional Information

Bryan K. Tolliver, M.D., Ph.D. (Principal Investigator)

Medical University of South Carolina

Phone: (843) 792-4869

Email: tollive@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place