Compulsive Sexual BehaviorPhase 2NCT00467558

Double-Blind Naltrexone in Compulsive Sexual Behavior

A Phase 2 study testing Naltrexone and Sugar pill in people with Compulsive Sexual Behavior, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Compulsive Sexual Behavior
What is being tested?: Naltrexone and Sugar pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: May 2007to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men and women age 21-75;
current diagnosis of compulsive sexual behavior

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 1 month) 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

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Read the detailed description

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Conditions: Compulsive Sexual Behavior
Being tested: Naltrexone, Sugar pill
Keywords: Impulse Control Disorder, Compulsive Sexual Behavior
Medical subject headings: Compulsive Sexual Behavior Disorder, Disruptive, Impulse Control, and Conduct Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaltrexoneDrug
Also called Revia
daily
Sugar pillDrug
daily

Study groups in NCT00467558
Study group	Role	What they receive
Naltrexone	Active comparator	Naltrexone 50mg-150mg by mouth per day. Receives: Drug: Naltrexone
Placebo	Placebo comparator	Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician Receives: Drug: Sugar pill

What is being measured

The primary outcome is the main question the study is designed to answer.

Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).
Measured: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Secondary outcomes (1)

Clinical Global Impression Scale - Severity
The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = "very much worse." The CGI severity scale was used at each visit and ranges from 1 = "not ill at all" to 7 = "among the most extremely ill."
Measured: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jun 2010

First posted30 Apr 2007 (estimated)
Study startMay 2007
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Compulsive Sexual BehaviorStudies of the same condition, open and under way.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467558
Sponsor's protocol ID: 0701M00804
Status last verified: Apr 2012
First submitted: 27 Apr 2007
Last updated: 18 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Compulsive Sexual Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior
ClinicalTrials.gov ID: NCT00467558
Acronym / sponsor ID: 0701M00804
Conditions: Compulsive Sexual Behavior
Keywords: Impulse Control Disorder, Compulsive Sexual Behavior
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: May 2007
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 30 Apr 2007 (estimated)
Results: Posted 18 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Naltrexone	Active comparator	Drug: NaltrexoneNaltrexone 50mg-150mg by mouth per day.
Placebo	Placebo comparator	Drug: Sugar pillPlacebo pills (1-3 pills daily) depending upon dose prescribed by study physician

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

men and women age 21-75;
current diagnosis of compulsive sexual behavior

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	Naltrexone
Sugar pilldaily	Drug	Placebo

Primary outcome

Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
Time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).

1 secondary outcome

Clinical Global Impression Scale - Severity
Time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Results and safety

Results posted to the registry on 18 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naltrexone	4	2
Placebo	3	3

Primary outcome: Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)

Time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8). Mean (Standard Deviation). Unit: units on a scale

Measure	Naltrexone n = 3	Placebo n = 3
Value	8 (7)	9.33 (1.15)

Population analysed: Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 and Sugar pill in people with Compulsive Sexual Behavior, 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: finished, as of the sponsor's last update on 18 May 2012. 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?

Yes. Results are posted in the registry (first posted 18 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Compulsive Sexual Behavior (YBOCS) (time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467558.

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 18 May 2012.