Phase 3
Completed N=21
Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
Source: ClinicalTrials.gov NCT00563797 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Number of Drinking Days — 17.6; 12.6 days — p=0.014
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinking Days |
17.6; 12.6 | 0.014 sig |
| PRIMARY Depression - Measured Using the HAMD Total Score |
8.212; 8.10 | .0001 sig |
| SECONDARY Mean Percentage of Number of Drinking Days by Smoking Status |
21.34; 4.57; 14.76; 48.81 | .025 sig |
| SECONDARY Mean Percentage of Heavy Drinking Days by Smoking |
15.14; 1.68; 3.57; 31.67 | .019 sig |
Eligibility Criteria
Inclusion Criteria
- Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence (AD) (using the SCID).
- Individuals who have been on a stable SSRI dose for 2 weeks.
- Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per day).
- 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).
- Women of childbearing potential must have a negative pregnancy test and use an acceptable method of contraception.
- 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
- Females who are pregnant or lactating.
- Patients may not be taking medications thought to influence drinking behavior, including: acamprosate, disulfiram, naltrexone, or ondansetron.
- 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.
- Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine.
- Patients who meet current SCID criteria for the following major Axis I diagnosis (Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
- 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).
- Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8) Patients taking bethanechol. (9) Patients at risk for suicide.
Data sourced from ClinicalTrials.gov (NCT00563797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.