Trial Outcomes & Findings for Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors (NCT NCT03530800)

Last Updated: 2022-06-02

Results Overview

The entire study lasts 10 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Assessed every two weeks up to 10 weeks, baseline data reported

Results posted on

2022-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Dronabinol Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary. Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)	Placebo Subjects will receive placebo for 10 weeks weeks. Placebo: Placebo for 10 weeks
Overall Study STARTED	25	25
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol n=25 Participants Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary. Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)	Placebo n=25 Participants Subjects will receive placebo for 10 weeks weeks. Placebo: Placebo for 10 weeks	Total n=50 Participants Total of all reporting groups
Age, Continuous	33.04 years STANDARD_DEVIATION 12.48 • n=5 Participants	28.36 years STANDARD_DEVIATION 7.27 • n=7 Participants	30.7 years STANDARD_DEVIATION 10.38 • n=5 Participants
Sex/Gender, Customized Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Any Psychiatric Diagnosis	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every two weeks up to 10 weeks, baseline data reported

Population: Data provided for subjects that reported data

Outcome measures

Outcome measures
Measure	Dronabinol n=13 Participants Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary. Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)	Placebo n=16 Participants Subjects will receive placebo for 10 weeks weeks. Placebo: Placebo for 10 weeks
NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS)	12.38 score on a scale Standard Deviation 3.15	10.63 score on a scale Standard Deviation 3.42

PRIMARY outcome

Timeframe: Assessed every two weeks up to 10 weeks, baseline reported

Population: Data provided for subjects that reported data

The entire study lasts 10 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of skin-picking symptoms. The SP-SAS score ranges from 0 to 48, with 0 being no symptoms and 48 being the most severe.

Outcome measures

Outcome measures
Measure	Dronabinol n=8 Participants Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary. Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)	Placebo n=6 Participants Subjects will receive placebo for 10 weeks weeks. Placebo: Placebo for 10 weeks
Skin Picking Symptom Assessment Scale (SP-SAS)	24.44 score on a scale Standard Deviation 9.46	28.5 score on a scale Standard Deviation 4.23

Adverse Events

Dronabinol

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dronabinol n=25 participants at risk Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary. Dronabinol: Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)	Placebo n=25 participants at risk Subjects will receive placebo for 10 weeks weeks. Placebo: Placebo for 10 weeks
General disorders Light headed/dizzy	20.0% 5/25 • Number of events 5 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	100.0% 1/1 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
General disorders High (easy laughing, elation, heightened awareness)	16.0% 4/25 • Number of events 4 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	0.00% 0/25 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
Psychiatric disorders Cognitive blunting, attentional problems	16.0% 4/25 • Number of events 4 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	8.0% 2/25 • Number of events 2 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
General disorders Sedation	20.0% 5/25 • Number of events 5 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	12.0% 3/25 • Number of events 3 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
General disorders Dry mouth	16.0% 4/25 • Number of events 4 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	8.0% 2/25 • Number of events 2 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
General disorders Headache	0.00% 0/25 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
Gastrointestinal disorders Nausea/vomiting	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
Psychiatric disorders Anxiety	8.0% 2/25 • Number of events 2 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.
General disorders Sleep disturbance	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.	4.0% 1/25 • Number of events 1 • Adverse event data was collected during the entire duration of the study (10 weeks). Subjects were asked about adverse events at each study visit and asked to reach out in between visits as well if needed to report adverse events. Definition does not differ from clinicaltrials.gov definition.

Additional Information

Dr. Jon E. Grant

University of Chicago

Phone: 7738341325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place