Alcohol Dependence
Conditions
Keywords
Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice
Brief summary
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).
Detailed description
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole. Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.
Interventions
DRUGAcamprosate
Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of alcohol dependence in the year before entering criminal justice supervision * Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia
Exclusion criteria
* Pregnant or nursing a baby * Known sensitivity to acamprosate * Elevated serum creatinine level or other evidence of kidney problems * Symptoms of severe depression or suicidal ideation * Non-English speaking such that they cannot provide informed consent * Cognitive impairment such that they cannot provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinking and Other Drug Use | 12 weeks | Number of participants using alcohol and other drugs during 12 weeks |
| Level of Acceptance | 12 weeks | Number of participants taking study medication during 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Drug Court | 12 weeks | Number of participants remaining in drug treatment court program during 12 weeks |
| Recidivism Rates | 12 weeks | Number of participants returning to jail during 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acamprosate Criminal justice supervisees given acamprosate for alcohol dependence | 14 |
| Control No specific intervention, monitored for outcomes | 12 |
| Total | 26 |
Baseline characteristics
| Characteristic | Control | Acamprosate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Continuous | 37.9 years STANDARD_DEVIATION 3 | 37.9 years STANDARD_DEVIATION 3 | 37.9 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 12 participants | 14 participants | 26 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 |
Outcome results
Primary
Drinking and Other Drug Use
Number of participants using alcohol and other drugs during 12 weeks
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acamprosate | Drinking and Other Drug Use | 6 participants |
Primary
Level of Acceptance
Number of participants taking study medication during 12 weeks
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acamprosate | Level of Acceptance | 13 participants |
Secondary
Recidivism Rates
Number of participants returning to jail during 12 weeks
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acamprosate | Recidivism Rates | 5 participants |
Secondary
Retention in Drug Court
Number of participants remaining in drug treatment court program during 12 weeks
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acamprosate | Retention in Drug Court | 13 participants |