Naltrexone & SSRI in Alcoholics With Depression/PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00338962
First received: June 15, 2006
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcoholism
Depression
PTSD
Interventions: Drug: paroxetine
Drug: desipramine
Drug: Naltrexone
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
No text entered.

Reporting Groups
  Description
Paroxetine and Naltrexone

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine and Placebo

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine and Naltrexone

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine and Placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo


Participant Flow:   Overall Study
    Paroxetine and Naltrexone     Paroxetine and Placebo     Desipramine and Naltrexone     Desipramine and Placebo  
STARTED     22     20     22     24  
COMPLETED     14     16     16     21  
NOT COMPLETED     8     4     6     3  
Lost to Follow-up                 3                 3                 2                 3  
Withdrawal by Subject                 1                 0                 0                 0  
No Transportation                 2                 0                 0                 0  
Time Constraint                 2                 0                 0                 0  
Moved                 0                 1                 0                 0  
Adverse Event                 0                 0                 2                 0  
Poor Compliance                 0                 0                 2                 0  



  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.
No text entered.

Reporting Groups
  Description
Paroxetine and Naltrexone

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine and Placebo

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine and Naltrexone

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine and Placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Total Total of all reporting groups

Baseline Measures
    Paroxetine and Naltrexone     Paroxetine and Placebo     Desipramine and Naltrexone     Desipramine and Placebo     Total  
Number of Participants  
[units: participants]
  22     20     22     24     88  
Age  
[units: years]
Mean (Standard Deviation)
  45.14  (6.71)     49.15  (8.95)     47.05  (9.96)     47.04  (9.72)     47.1  (8.90)  
Gender  
[units: participants]
         
Female     0     1     4     3     8  
Male     22     19     18     21     80  



  Outcome Measures
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1.  Primary:   Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)   [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]

2.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]

3.  Primary:   Hamilton Depression Rating Scale (HAM-D)   [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]

4.  Primary:   Mean Number of Side Effects   [ Time Frame: 12 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
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  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
phone: 203-932-5711 ext 4282
e-mail: elizabeth.ralevski@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00338962     History of Changes
Other Study ID Numbers: HIC # 11637
Study First Received: June 15, 2006
Results First Received: November 4, 2015
Last Updated: January 6, 2016
Health Authority: United States: Institutional Review Board