Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: acamprosate; placebo
Intervention description: 1998 mg/dau fpr 8 weeks; placebo pills
Intervention MeSH terms: Acamprosate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cocaine

Summary:

      Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of
      cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male and females 18 years of age or older.

          2. Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined
             by The Structured Clinical Interview for DSM-IV (SCID-IV).

          3. Subject used cocaine in the past 30 days totaling at least $200 worth of cocaine.
             Cocaine use will be determined by utilizing the modified Timeline Followback,
             crosschecked with the ASI, which inquires about dollar amounts spent on drug use.

          4. Subject lives a commutable distance from the TRC and agrees to attend all research
             visits, including follow-up visits.

          5. Subject speaks, understands, and prints in English.

          6. Written informed consent signed by the subject.

        Exclusion Criteria

          1. Subjects mandated to treatment based upon a legal decision or as a condition of
             employment.

          2. Subjects with evidence of current substance dependence other than cocaine, alcohol or
             nicotine dependence, as determined by the SCID-IV.

          3. Subjects who meets DSM-IV criteria for current alcohol dependence who require a
             medical alcohol detoxification.

          4. Requires treatment with any psychoactive medications, including any anti-seizure
             medications (with the exception of Benadryl used sparingly, if necessary, for sleep).

          5. Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any
             psychotic disorder, or organic mental disorder. Has current DSM-IV diagnosis of any
             other clinically significant psychiatric disorder that will interfere with study
             participation, as determined by the study physician or PI (Drs. Kyle Kampman, Charles
             Dackis and Helen Pettinati).

          6. Female subjects who are pregnant or lactating, or female subjects of childbearing
             potential who are not using acceptable methods of birth control. Acceptable methods of
             birth control include: barrier (diaphragm or condom) with spermicide, intrauterine
             progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate
             contraceptive injection, and oral contraceptives.

          7. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
             that are clinically unacceptable to the Principal Investigator. EKG-1st 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. Eligibility will be
             determined by most recent lab results collected prior to randomization.

          8. Subjects with impaired renal function as indicated by corrected creatinine clearance
             below 80 ml/min/70 kg as determined by the modified Cockcroft equation (Center for
             Disease Control, 1986).

          9. 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).

         10. History of significant heart disease (an arrhythmia which required medication, angina
             pectoris, documented history of myocardial infarction, or heart failure).

         11. Known hypersensitivity to acamprosate.

         12. Subjects having participated in any investigational drug trial within 30 days prior to
             randomizing into the study.

         13. Subjects with any serious illnesses that may require hospitalization during the study,
             as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and
             Helen Pettinati).