TrichotillomaniaPhase 2NCT00775229
Naltrexone in the Treatment of Trichotillomania
A Phase 2 study testing Naltrexone in people with Trichotillomania, run by University of Chicago at 1 site in United States.
Trial summary
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women age 18-75;
- current DSM-IV trichotillomania;
- hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Who cannot join
- unstable medical illness or clinically significant abnormalities on pre-study 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 for the treatment of trichotillomania 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;
- lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- current use of opiates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
Read the detailed description
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
- Conditions
- Trichotillomania
- Being tested
- Naltrexone, Placebo
- Keywords
- hair pulling
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called ReVia
pill, by mouth, 50mg-150mg/day for the duration of the study
PlaceboDrug
Also called also known as a 'sugar pill'
pill, by mouth, 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.
National Institute of Mental Health Trichotillomania Symptom Severity Scale
Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
Measured: This is the final score, measured at week 8 (final visit).
Secondary outcomes (2)
Massachusetts General Hospital Hairpulling Scale
Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
Measured: This is the final score, measured at week 8 (final visit).
Liver Function Tests
Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).
Measured: Week 8 (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2012
- Study completionDec 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- 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
- NCT00775229
- Sponsor's protocol ID
- 0806M36061
- Status last verified
- Feb 2023
- First submitted
- 16 Oct 2008
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
PubMed 34582562Odlaug BL, Chamberlain SR, Harvanko AM, Grant JE. Age at onset in trichotillomania:clinical variables and neurocognitive performance. Prim Care Companion CNS Disord. 2012;14(4):PCC.12m01343. doi: 10.4088/PCC.12m01343. Epub 2012 Jul 19.
PubMed 23251869
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania
- ClinicalTrials.gov ID
- NCT00775229
- Acronym / sponsor ID
- 0806M36061
- Conditions
- Trichotillomania
- Keywords
- hair pulling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
Detailed description
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NaltrexoneNaltrexone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women age 18-75;
- current DSM-IV trichotillomania;
- hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Key exclusion criteria (13 listed)
- unstable medical illness or clinically significant abnormalities on pre-study 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: ReViapill, by mouth, 50mg-150mg/day for the duration of the study | Drug | 1 |
| PlaceboAlso: also known as a 'sugar pill'pill, by mouth, daily | Drug | 2 |
Primary outcome
National Institute of Mental Health Trichotillomania Symptom Severity Scale
Time frame: This is the final score, measured at week 8 (final visit).
Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
2 secondary outcomes
Massachusetts General Hospital Hairpulling Scale
Time frame: This is the final score, measured at week 8 (final visit).
Liver Function Tests
Time frame: Week 8 (last visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34582562Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
- Derived from this study: PubMed 23251869Odlaug BL, Chamberlain SR, Harvanko AM, Grant JE. Age at onset in trichotillomania:clinical variables and neurocognitive performance. Prim Care Companion CNS Disord. 2012;14(4):PCC.12m01343. doi: 10.4088/PCC.12m01343. Epub 2012 Jul 19.
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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 in people with Trichotillomania, run by University of Chicago 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 3 inclusion and 13 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 23 Feb 2023. 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 17 Mar 2014). 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?
National Institute of Mental Health Trichotillomania Symptom Severity Scale (time frame: This is the final score, measured at week 8 (final visit).). 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 NCT00775229, which also lists 2 linked publications.
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 23 Feb 2023.