Naltrexone & SSRI in Alcoholics With Depression/PTSD
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2001 |
| End Date: | July 2015 |
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.
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.
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.
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.
Inclusion Criteria:
- DSM-IV diagnosis of alcohol dependence and current DSM-IV depressive disorder or PTSD
- a recent episode of heavy drinking
- outpatient, sober from alcohol and other abused substance for at least 2 days before
randomization
- stable medication regiment for at least 2 weeks
- women on adequate methods of contraception
Exclusion Criteria:
- current opioid dependence or abuse
- history (within the last 3 months) of opioid dependence or abuse
- pregnant
- history of psychotic disorders or current treatment with antipsychotic medications
- medication thought to influence drinking including: acamprosate, disulfiram,
naltrexone, ondansetron, valproic acid or tegretol
- current (within the lst 6 months) use of MAO inhibitors
- suicidal active ideation or intent
- significant underlying medical condition
- history of cardiac condition abnormalities
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