Naltrexone in the Treatment of Pyromania
Overview
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
Full Title of Study: “A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 2010
Detailed Description
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Interventions
- Drug: Naltrexone
- daily
- Drug: Placebo
- daily
Arms, Groups and Cohorts
- Active Comparator: 1
- Naltrexone
- Placebo Comparator: 2
- Placebo
Clinical Trial Outcome Measures
Primary Measures
- Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
- Time Frame: At each visit
Secondary Measures
- Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
- Time Frame: At each visit
Participating in This Clinical Trial
Inclusion Criteria
1. men and women age 16-75; 2. current DSM-IV pyromania Exclusion Criteria:
1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; 2. history of seizures; 3. myocardial infarction within 6 months; 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. clinically significant suicidality; 6. current or recent (past 3 months) DSM-IV substance abuse or dependence; 7. illegal substance within 2 weeks of study initiation; 8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; 9. initiation of a psychotropic medication within 2 months prior to study inclusion; 10. previous treatment with naltrexone; and 11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Minnesota
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jon E Grant, M.D., Principal Investigator, University of Minnesota
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