Acamprosate Initiated During Alcohol Detoxification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-11-30

Brief Summary

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Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with acamprosate.

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Detailed Description

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Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment phase (RP).

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Acamprosate

Group Type EXPERIMENTAL

Acamprosate

Intervention Type DRUG

3 pills (666 mg) for 1998mg/day

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 pills (666mg) for 1998mg/day

Interventions

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Acamprosate

3 pills (666 mg) for 1998mg/day

Intervention Type DRUG

Placebo

3 pills (666mg) for 1998mg/day

Intervention Type DRUG

Other Intervention Names

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Campral

Eligibility Criteria

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Inclusion Criteria

1. Males and females from the ages of 18 to 70 years old. Subjects over the age of 70 years old will be included at the discretion of the PI, with the expectation that these subjects should comprise of no more than 5% of the subjects.
2. Diagnosis of current alcohol dependence according to DSM-IV criteria \[DSM-IV criteria will be determined by utilizing the Mini International Neuropsychiatric Interview (MINI)\].
3. If necessary, can be medically detoxified in the outpatient setting, as determined by a medical clinician.
4. Meets the following drinking criteria, measured by TLFB: a. reports a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting pharmacotherapy, b. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) within 30 days of starting pharmacotherapy treatment and c. has had a drink within 48 hours of the intake/screening visit or has a CIWA score equal to or greater than 3.
5. Speaks, understands and prints in English.
6. Gives written informed consent.

1. Has taken at least 5 days of acamprosate or placebo directly prior to initiating open-label acamprosate.
2. Successfully completed, within a 14-day period, outpatient detoxification. Successful completion of detoxification is defined as having a score of 1 or lower on the Clinical Institutes Withdrawal Assessment for Alcohol (CIWA; Shaw et al., 1981), and has at least 3 consecutive days of abstinence.
3. Has reduced medication taken specifically for detoxification (if applicable), i.e., oxazepam to 45 mg within 24-hour period prior to the post-detoxification rehabilitative treatment phase.

Exclusion Criteria

1. Subjects mandated to treatment based upon a legal decision or as a condition of employment.
2. Subjects with evidence of substance dependence other than alcohol or nicotine dependence.
3. Subjects with psychosis or dementia at the time of the initial evaluation.
4. Female Subjects who are pregnant or lactating, or female Subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include: tubal ligation, barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, and oral contraceptives.
5. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG first degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests \[LFTs\] \<5 x ULN are acceptable), Subjects with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
6. Subjects who have a positive urine drug screening (cocaine, amphetamines, opiates, barbiturates, benzodiazepines)
7. Subjects who have any disease of the gastrointestinal tract, liver or kidneys that could result in a possibility of altered metabolism or excretion of the study drug. As it is not possible to enumerate the many conditions which might impair absorption, metabolism, or excretion, the investigators will be guided by evidence such as: History of major gastrointestinal tract surgery (gastrectomy, gastrostomy, bowel resection, etc.) or a history of an active peptic ulcer or chronic disease of the GI tract, (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).
8. Current unstable heart disease.
9. Known hypersensitivity to acamprosate.
10. Subjects taking psychotropic drugs (e.g., antidepressants, anxiolytic, antipsychotic, naltrexone, disulfiram, modafinil, stimulants and anticonvulsants) with the exception of oxazepam
11. Subjects receiving formal psychotherapy
12. Subjects having participated in any investigational drug trial within 30 days prior to the study.
13. Subjects with AIDS or other serious illnesses that may require hospitalization during the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No