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Trial record 31 of 47 for:    DESIPRAMINE

Naltrexone & SSRI in Alcoholics With Depression/PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00338962
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE June 15, 2006
First Posted Date  ICMJE June 20, 2006
Results First Submitted Date  ICMJE November 4, 2015
Results First Posted Date  ICMJE February 5, 2016
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE October 2001
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]
    The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]
    The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: beginning of treatment (week 1), and end of treatment (13 weeks) ]
    The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)
  • Mean Number of Side Effects [ Time Frame: 12 weeks ]
    Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
  • self-report weekly alcohol consumption
  • self-report weekly craving
  • weekly psychiatric and emotional distress
  • weekly psychiatric symptoms of depression and PTSD
  • side effects
Change History Complete list of historical versions of study NCT00338962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
weekly quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone & SSRI in Alcoholics With Depression/PTSD
Official Title  ICMJE Naltrexone & SSRI in Alcoholics With Depression/PTSD
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcoholism
  • Depression
  • PTSD
Intervention  ICMJE
  • Drug: paroxetine
    paroxetine (40mg/day)
    Other Name: paxil
  • Drug: desipramine
    200 mg per day
    Other Name: Norpramin
  • Drug: Naltrexone
    50 mg per day
    Other Name: Vivitrol
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: 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.
    Interventions:
    • Drug: paroxetine
    • Drug: Naltrexone
  • Active Comparator: 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.
    Interventions:
    • Drug: paroxetine
    • Drug: Placebo
  • Active Comparator: 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.
    Interventions:
    • Drug: desipramine
    • Drug: Naltrexone
  • Active Comparator: 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.
    Interventions:
    • Drug: desipramine
    • Drug: Placebo
Publications * Petrakis IL, Ralevski E, Desai N, Trevisan L, Gueorguieva R, Rounsaville B, Krystal JH. Noradrenergic vs serotonergic antidepressant with or without naltrexone for veterans with PTSD and comorbid alcohol dependence. Neuropsychopharmacology. 2012 Mar;37(4):996-1004. doi: 10.1038/npp.2011.283. Epub 2011 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2016)
88
Original Enrollment  ICMJE
 (submitted: June 19, 2006)
120
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00338962
Other Study ID Numbers  ICMJE HIC # 11637
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ismene Petrakis, M.D. Yale University
PRS Account Yale University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP