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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00338962 |
The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.
We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
Condition | Intervention | Phase |
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Alcoholism Depression PTSD |
Drug: paroxetine, desipramine, naltrexone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Naltrexone & SSRI in Alcoholics With Depression/PTSD |
Estimated Enrollment: | 120 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SSRI: Active Comparator
Paxil plus either naltrexone or placebo
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Drug: paroxetine, desipramine, naltrexone
paroxetine (40mg/day) plus either naltrexone (600mg/week) or placebo desipramine (200mg/day) plus either naltrexone (600mg/week) or placebo
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Desipramine: Active Comparator
Desipramine plus naltrexone or placebo
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Drug: paroxetine, desipramine, naltrexone
paroxetine (40mg/day) plus either naltrexone (600mg/week) or placebo desipramine (200mg/day) plus either naltrexone (600mg/week) or placebo
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OBJECTIVE: Alcoholics with current comorbid mental disorders constitute the majority of alcoholics in clinical settings. Although there are two FDA approved medications for the treatment of alcoholism (naltrexone and disulfiram), there are no established pharmacotherapies for individuals with comorbid alcoholism and psychiatric illnesses. Studies suggest that the class of antidepressants known as serotonin selective reuptake inhibitors (SSRIs) is effective in reducing alcohol use in depressed individuals. In addition, a small open label study has shown that SSRIs have similar effects on individuals with comorbid PTSD and alcoholism. Preclinical studies have shown that the combination of a serotonergic agent and naltrexone was more effective than either medication alone in suppressing alcohol intake. To address this issue, we are conducting a 13 week randomized clinical trial evaluating the effects of paroxetine, desipramine and naltrexone in reducing alcohol use in alcohol dependent individuals who currently meet DSM-IV diagnosis for Depressive Disorder or PTSD. RESEARCH PLAN: One hundred and twenty subjects who are alcohol dependent patients with comorbid PTSD or Depressive Disorder will be recruited from the following West Haven VA sources: the Substance Abuse Treatment program, the PTSD clinic, the Women's clinic, clinical referrals and advertisement. These subjects will be randomized in a double-blind fashion to one of four cells. We will compare paroxetine versus desipramine and naltrexone versus placebo. The antidepressant will be started at a low dose and titrated upward on a fixed schedule. The target dose will be 40mg for paroxetine and 200mg for desipramine. Minimum dosage permitted for study retention will be 20mg for paroxetine and 150mg for desipramine. Pharmacological treatments will last 13 weeks. Psychosocial treatment will involve medication compliance therapy, using the Microelectric Event Monitoring (MEMS) bottle caps. The specific aim of the research is to compare the relative effectiveness of paroxetine versus desipramine and naltrexone versus placebo in reducing the quantity and frequency of alcohol consumption. METHODOLOGY: The primary outcome measures of major interest will include: frequency and quantity of alcohol consumption, self-reported craving, self-reported psychiatric and emotional distress, diagnostic assessment or psychiatric symptoms and side effects. These outcomes will be measured by the following: self-assessments, Timeline Followback, Hamilton Depression and anxiety scales, CAPS, ASI, Quality of Life, breathalyzer tests and monthly liver function tests.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
VA Connecticut Healthcare Systems | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Ismene Petrakis, M.D. | Yale University |
Responsible Party: | Yale University ( Ismene Petrakis, MD ) |
Study ID Numbers: | HIC # 11637 |
Study First Received: | June 15, 2006 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00338962 |
Health Authority: | United States: Institutional Review Board |
SSRI treatment naltrexone alcohol dependence |
Desipramine depression PTSD |
Depression Stress Disorders of Environmental Origin Desipramine Depressive Disorder Paroxetine Serotonin Stress Disorders, Traumatic Behavioral Symptoms |
Anxiety Disorders Mental Disorders Naltrexone Alcoholism Substance-Related Disorders Mood Disorders Stress Disorders, Post-Traumatic Alcohol-Related Disorders Ethanol |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Narcotic Antagonists Physiological Effects of Drugs Psychotropic Drugs Enzyme Inhibitors Serotonin Uptake Inhibitors |
Pharmacologic Actions Antidepressive Agents, Tricyclic Serotonin Agents Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |