Naltrexone in the Treatment of Pyromania

A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00467454

Enrollment

Registered

2007-04-30

Start date

2007-06-30

Completion date

2010-04-30

Last updated

2011-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyromania

Keywords

Pyromania, Fire Setting, Compulsive Fire Setting

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.

Interventions

DRUGNaltrexone

daily

DRUGPlacebo

daily

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)	At each visit

Secondary

Measure	Time frame
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory	At each visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026