Clinical trial NCT00360594 (phase 2, status: completed)
Conditions: alcohol use disorder
ICD codes: F10.94, F10.980, F10.982, F10.988, F10.99, F10.959, F10.96
Drugs: acamprosate, placebo
SMILES: CC(=O)NCCCS(O)(=O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria for Detoxification Treatment Phase

          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.

        Exclusion Criteria for Detoxification Treatment Phase (DP)

          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.

        Inclusion Criteria for Post-Detoxification Rehabilitative Treatment Phase (RP/Phase 2) with
        Open-Label Acamprosate

          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.