KleptomaniaPhase 2NCT00332579
Double-Blind Naltrexone in Kleptomania
A Phase 2 study testing Naltrexone in people with Kleptomania, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Kleptomania
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2006to 1 Sep 2008
- 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 DSM-IV kleptomania.
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
Show all 11Show fewer
- illegal substance within 2 weeks of study initiation
- initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
- initiation of a psychotropic medication within 2 months prior to study inclusion
- previous treatment with naltrexone
- 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 Kleptomania
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Read the detailed description
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
- Conditions
- Kleptomania
- Being tested
- Naltrexone, Placebo
- Keywords
- Compulsive Shoplifting, Kleptomania, Compulsive Stealing
- Medical subject headings
- 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
PlaceboDrug
daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Naltrexone Receives: Drug: Naltrexone |
| B | 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 Kleptomania (K-YBOCS)
The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
Measured: K-YBOCS is done at each visit by the investigator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study start1 May 2006
- Primary completion1 Sep 2008
- Study completion1 Sep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KleptomaniaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, MD, JD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332579
- Sponsor's protocol ID
- 0602M82626
- Status last verified
- Jul 2019
- First submitted
- 30 May 2006
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grant JE, Kim SW, Odlaug BL. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania. Biol Psychiatry. 2009 Apr 1;65(7):600-6. doi: 10.1016/j.biopsych.2008.11.022. Epub 2009 Feb 12.
PubMed 19217077
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
- ClinicalTrials.gov ID
- NCT00332579
- Acronym / sponsor ID
- 0602M82626
- Conditions
- Kleptomania
- Keywords
- Compulsive Shoplifting, Kleptomania, Compulsive Stealing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Sep 2008 (actual)
- Study completion
- 1 Sep 2008 (actual)
- First posted
- 1 Jun 2006 (estimated)
- Results
- Posted 4 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Detailed description
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. 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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: NaltrexoneNaltrexone |
| B | Placebo comparator | Drug: PlaceboPlacebo |
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 DSM-IV kleptomania.
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 | A |
| Placebodaily | Drug | B |
Primary outcome
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
Time frame: K-YBOCS is done at each visit by the investigator.
The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19217077Grant JE, Kim SW, Odlaug BL. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania. Biol Psychiatry. 2009 Apr 1;65(7):600-6. doi: 10.1016/j.biopsych.2008.11.022. Epub 2009 Feb 12.
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, MD, JD 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 Kleptomania, 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 29 Jul 2019. 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 4 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 Kleptomania (K-YBOCS) (time frame: K-YBOCS is done at each visit by the investigator.). 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 NCT00332579, which also lists 1 linked publication.
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 29 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.