Trial Outcomes & Findings for Marinol in Trichotillomania or Obsessive Compulsive Disorder (NCT NCT01093976)

Results Overview

The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Subjects were followed for their duration of participation in the study (12-weeks)

Results posted on

2023-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Dronabinol Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Marinol in Trichotillomania or Obsessive Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol n=14 Participants Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	33.29 years STANDARD_DEVIATION 8.86 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: Subjects were followed for their duration of participation in the study (12-weeks)

Population: Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).

The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.

Outcome measures

Outcome measures
Measure	Dronabinol n=14 Participants Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score	8.71 units on a scale Standard Deviation 5.48

Adverse Events

Dronabinol

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dronabinol n=14 participants at risk Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Psychiatric disorders Light-headed / dizziness	28.6% 4/14 • Number of events 4

Additional Information

Jon E. Grant

University of Minnesota

Phone: 612-273-9800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place