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Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors

NCT03530800 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-02

Study results available
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Summary

The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in trichotillomania and other body-focused repetitive behaviors such as skin-picking disorder. 50 subjects with DSM-5 trichotillomania or skin-picking disorder will receive 10 weeks of double-blind dronabinol or placebo. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with trichotillomania and/or skin-picking disorder compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lacks a clearly effective treatment.

Conditions

  • Trichotillomania
  • Skin-Picking

Interventions

DRUG

Dronabinol

Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)

DRUG

Placebo

Placebo for 10 weeks

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Jon E Grant, JD, MD, MPH · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-07-20
Completion
2021-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530800 on ClinicalTrials.gov