NCT00467454WithdrawnPhase 2
A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Minnesota
- Locations
- 1
- Primary Endpoint
- Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Study Overview
Brief Summary
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •men and women age 16-75;
- •current DSM-IV pyromania
Exclusion Criteria
- •unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- •history of seizures;
- •myocardial infarction within 6 months;
- •current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •clinically significant suicidality;
- •current or recent (past 3 months) DSM-IV substance abuse or dependence;
- •illegal substance within 2 weeks of study initiation;
- •initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
- •initiation of a psychotropic medication within 2 months prior to study inclusion;
- •previous treatment with naltrexone; and
- •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
Arms & Interventions
1
Active Comparator
Naltrexone
Intervention: Naltrexone (Drug)
2
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Time Frame: At each visit
Secondary Outcomes
- Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory(At each visit)
Investigators
Study Sites (1)
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