Trial Outcomes & Findings for Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees (NCT NCT00249379)

Results Overview

Number of participants using alcohol and other drugs during 12 weeks

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Acamprosate Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period	Control No specific intervention, received standard Drug Court counseling, monitored for outcomes
Overall Study STARTED	14	12
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acamprosate n=14 Participants Criminal justice supervisees given acamprosate for alcohol dependence	Control n=12 Participants No specific intervention, monitored for outcomes	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	37.9 years STANDARD_DEVIATION 3 • n=93 Participants	37.9 years STANDARD_DEVIATION 3 • n=4 Participants	37.9 years STANDARD_DEVIATION 3 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	12 participants n=4 Participants	26 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Number of participants using alcohol and other drugs during 12 weeks

Outcome measures

Outcome measures
Measure	Acamprosate n=13 Participants participants taking study medication	Control
Drinking and Other Drug Use	6 participants	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Number of participants taking study medication during 12 weeks

Outcome measures

Outcome measures
Measure	Acamprosate n=13 Participants participants taking study medication	Control
Level of Acceptance	13 participants	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Number of participants remaining in drug treatment court program during 12 weeks

Outcome measures

Outcome measures
Measure	Acamprosate n=13 Participants participants taking study medication	Control
Retention in Drug Court	13 participants	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Number of participants returning to jail during 12 weeks

Outcome measures

Outcome measures
Measure	Acamprosate n=13 Participants participants taking study medication	Control
Recidivism Rates	5 participants	—

Adverse Events

Acamprosate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Weaver, MD

Virginia Commonwealth University

Phone: 804-828-1283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place