Trichotillomania
Conditions
Keywords
hair pulling
Brief summary
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.
Interventions
DRUGNaltrexone
pill, by mouth, 50mg-150mg/day for the duration of the study
DRUGPlacebo
pill, by mouth, daily
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. men and women age 18-75; 2. current DSM-IV trichotillomania; 3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Exclusion criteria
1. unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination; 2. history of seizures; 3. myocardial infarction within 6 months; 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. clinically significant suicidality; 6. current or recent (past 3 months) DSM-IV substance abuse or dependence; 7. illegal substance within 2 weeks of study initiation; 8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline; 9. initiation of a psychotropic medication within 2 months prior to study inclusion; 10. previous treatment with naltrexone; and 11. 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; 12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 13. current use of opiates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Mental Health Trichotillomania Symptom Severity Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Massachusetts General Hospital Hairpulling Scale | This is the final score, measured at week 8 (final visit). | 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. |
| Liver Function Tests | Week 8 (last visit) | 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). |
Countries
United States
Participant flow
Recruitment details
Men and women aged 18 to 75 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of TTM were recruited through newspaper advertisements and referrals.
Pre-assignment details
Exclusion: unstable medical illness, current pregnancy or inadequate contraception, thoughts of suicide,history of bipolar disorder,dementia, or psychotic disorder,past 12 months SUD, previous treatment with naltrexone, initiation of behavior therapy within the last 6 months, initiation of a psychotropic medication within the last 3months, opiates.
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Naltrexone
Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study | 25 |
| Placebo Placebo
Placebo : pill, by mouth, daily | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | Placebo | Naltrexone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 51 Participants |
| Age, Continuous | 34.0 years STANDARD_DEVIATION 10.1 | 32.2 years STANDARD_DEVIATION 9.4 | 32.7 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 25 | 1 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 |
Outcome results
Primary
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.
Time frame: This is the final score, measured at week 8 (final visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | National Institute of Mental Health Trichotillomania Symptom Severity Scale | 7.94 units on a scale | Standard Deviation 4.835 |
| Placebo | National Institute of Mental Health Trichotillomania Symptom Severity Scale | 8.73 units on a scale | Standard Deviation 5.481 |
Secondary
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).
Time frame: Week 8 (last visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naltrexone | Liver Function Tests | 0 percentage of individuals with LFT chang |
| Placebo | Liver Function Tests | 0 percentage of individuals with LFT chang |
Secondary
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.
Time frame: This is the final score, measured at week 8 (final visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Massachusetts General Hospital Hairpulling Scale | 12.21 units on a scale | Standard Deviation 6.203 |
| Placebo | Massachusetts General Hospital Hairpulling Scale | 13.35 units on a scale | Standard Deviation 4.749 |