Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
Condition: Alcohol Dependence; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Intervention: Mecamylamine; Placebo
Intervention description: mecamylamine 10mg/day for 12 weeks; Placebo pill
Intervention MeSH terms: Mecamylamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: treatment; alcohol dependence; depression; mecamylamine

Summary:

      The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day)
      versus placebo in reducing depressive and alcohol symptoms in patients with depression and
      co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce
      depressive symptoms and decrease alcohol consumption compared to placebo in patients with
      depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake
      inhibitor (SSRI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence
             (AD) (using the SCID).

          2. Individuals who have been on a stable SSRI dose for 2 weeks.

          3. Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per
             day).

          4. Individuals who have a history of substance dependence (other than alcohol, tobacco
             and cocaine) but have not met criteria for substance dependence in the past 30 days
             will be included (using the SCID).

          5. Women of childbearing potential must have a negative pregnancy test and use an
             acceptable method of contraception.

          6. Individuals who are able to participate psychologically and physically; give informed
             consent; complete the assessments; take the study medication; and otherwise
             participate in the trial. A post-consent test will be given to assess patient's
             capacity to give informed consent.

        Exclusion Criteria:

          1. Females who are pregnant or lactating.

          2. Patients may not be taking medications thought to influence drinking behavior,
             including: acamprosate, disulfiram, naltrexone, or ondansetron.

          3. Patients with significant underlying medical conditions, such as cerebral, renal,
             thyroid, hepatic or cardiac pathology, which in the opinion of the physician would
             preclude the patient from fully cooperating or be of potential harm during the course
             of the study.

          4. Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction,
             cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to
             mecamylamine.

          5. Patients who meet current SCID criteria for the following major Axis I diagnosis
             (Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and
             Schizophrenia-type Disorders).

          6. Patients with a current unstable medical condition such as neurological,
             cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT more than 5 times
             normal, abnormal BUN and creatinine, and unmanaged hypertension with BP higher than
             200/120).

          7. Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8)
             Patients taking bethanechol. (9) Patients at risk for suicide.