Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00563797
First received: November 21, 2007
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Depression
Interventions: Drug: Mecamylamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
284 subjects were assessed for eligibility, but 263 were excluded because they did not meet inclusion criteria or did not want to participate.

Reporting Groups
  Description
Mecamylamine

Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.

Mecamylamine: mecamylamine 10mg/day for 12 weeks

Placebo

Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.

Placebo: Placebo pill


Participant Flow:   Overall Study
    Mecamylamine     Placebo  
STARTED     11     10  
Received Allocated Intervention     11     10  
Follow-Up     11     10  
COMPLETED     4     8  
NOT COMPLETED     7     2  
Lost to Follow-up                 7                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were included in the study if they met criteria for major depression and alcohol dependence, had been on a stable antidepressant dose for 2 weeks, and were either smokers or nonsmokers.

Reporting Groups
  Description
Mecamylamine

Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.

Mecamylamine: mecamylamine 10mg/day for 12 weeks

Placebo

Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.

Placebo: Placebo pill

Total Total of all reporting groups

Baseline Measures
    Mecamylamine     Placebo     Total  
Number of Participants  
[units: participants]
  11     10     21  
Age  
[units: years]
Mean (Standard Deviation)
  50.91  (8.43)     48.20  (9.84)     49.62  (9.00)  
Gender  
[units: participants]
     
Female     2     4     6  
Male     9     6     15  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     7     9     16  
African American     4     1     5  
Drinks per drinking day  
[units: drinks per day]
Mean (Standard Deviation)
  13.56  (8.27)     9.32  (8.99)     11.54  (8.68)  
Drinking days, past 30  
[units: drinking days]
Mean (Standard Deviation)
  22.55  (7.50)     22.10  (8.57)     22.33  (7.83)  
Heavy drinking days, past 30 [1]
[units: days]
Mean (Standard Deviation)
  21.73  (7.38)     18.00  (11.62)     19.95  (9.57)  
Cigarettes per day  
[units: cigarettes]
Mean (Standard Deviation)
  13.6  (7.8)     16.6  (4.50)     14.9  (6.60)  
Total Alcohol Dependence Scale (ADS) score [2]
[units: units on a scale]
Mean (Standard Deviation)
  17.70  (10.34)     21.7  (9.72)     19.70  (9.98)  
Depression HAMD [3]
[units: units on a scale]
Mean (Standard Deviation)
  13.64  (5.43)     12.90  (2.93)     13.29  (4.32)  
Smoking Status  
[units: participants]
     
Smokers     7     5     12  
Non-Smokers     4     5     9  
[1] Heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women
[2] The Alcohol Dependence Scale is made of 25 items that cover alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior. The scale can range from 0 to 47. The higher the value the greater the dependence. A score of 9 or more is highly predictive of DSM diagnosis of alcohol dependence. More specifically, a score from 1-13 indicates low dependence, 14-21 indicates intermediate, 22-30 indicates substantial, and 31-47 severe level of alcohol dependence.
[3]

The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient’s level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients.

Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression)




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Drinking Days   [ Time Frame: 25 weeks ]

2.  Primary:   Depression - Measured Using the HAMD Total Score   [ Time Frame: 12 weeks ]

3.  Secondary:   Mean Percentage of Number of Drinking Days by Smoking Status   [ Time Frame: 25 weeks ]

4.  Secondary:   Mean Percentage of Heavy Drinking Days by Smoking   [ Time Frame: 25 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elizabeth Ralevski
Organization: Yale University School Of Medicine Department of Psychiatry
phone: 203-932-5711 ext 4282
e-mail: elizabeth.ralevski@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00563797     History of Changes
Other Study ID Numbers: 0705002629
Study First Received: November 21, 2007
Results First Received: November 16, 2015
Last Updated: March 21, 2016
Health Authority: United States: Institutional Review Board