PyromaniaPhase 2NCT00467454
Naltrexone in the Treatment of Pyromania
A Phase 2 study testing Naltrexone in people with Pyromania, run by University of Minnesota at 1 site in United States.
Trial summary
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Pyromania
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- men and women age 16-75;
- current DSM-IV pyromania
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: 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.
Read the 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.
- Conditions
- Pyromania
- Being tested
- Naltrexone, Placebo
- Keywords
- Pyromania, Fire Setting, Compulsive Fire Setting
- Medical subject headings
- Firesetting Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
daily
PlaceboDrug
daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Naltrexone Receives: Drug: Naltrexone |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Measured: At each visit
Secondary outcomes (1)
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Funding allocation to different clinical trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyromaniaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467454
- Sponsor's protocol ID
- 0703M04084
- Status last verified
- Dec 2011
- First submitted
- 27 Apr 2007
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
- ClinicalTrials.gov ID
- NCT00467454
- Acronym / sponsor ID
- 0703M04084
- Conditions
- Pyromania
- Keywords
- Pyromania, Fire Setting, Compulsive Fire Setting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding allocation to different clinical trials.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NaltrexoneNaltrexone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- men and women age 16-75;
- current DSM-IV pyromania
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Reviadaily | Drug | 1 |
| Placebodaily | Drug | 2 |
Primary outcome
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Time frame: At each visit
1 secondary outcome
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
Time frame: At each visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon E Grant, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Pyromania, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS) (time frame: At each visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.