- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467454
Naltrexone in the Treatment of Pyromania
December 13, 2011 updated by: University of Minnesota
A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
Study Overview
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 Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
daily
|
Active Comparator: 1
Naltrexone
|
daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Time Frame: At each visit
|
At each visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
Time Frame: At each visit
|
At each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jon E Grant, M.D., University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
April 27, 2007
First Submitted That Met QC Criteria
April 27, 2007
First Posted (Estimate)
April 30, 2007
Study Record Updates
Last Update Posted (Estimate)
December 14, 2011
Last Update Submitted That Met QC Criteria
December 13, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0703M04084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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