Study Stopped
Funding allocation to different clinical trials.
Naltrexone in the Treatment of Pyromania
A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2007
CompletedFirst Posted
Study publicly available on registry
April 30, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedDecember 14, 2011
December 1, 2011
2.8 years
April 27, 2007
December 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
At each visit
Secondary Outcomes (1)
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
At each visit
Study Arms (2)
1
ACTIVE COMPARATORNaltrexone
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- men and women age 16-75;
- current DSM-IV pyromania
You may not qualify if:
- 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;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Grant, M.D.
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2007
First Posted
April 30, 2007
Study Start
June 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
December 14, 2011
Record last verified: 2011-12