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Trial Outcomes & Findings for Nabilone in Cannabis Users With PTSD (NCT NCT03251326)

NCT ID: NCT03251326

Last Updated: 2022-07-15

Results Overview

We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

1 month

Results posted on

2022-07-15

Participant Flow

The study was terminated and the PI and the study team left the institution; as such, no outcome data is available.

Participant milestones

Participant milestones
Measure
Active Nab > Plac Prop > Plac Cann
Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
Plac Nab > Act Prop > Plac Cann
Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC)
Plac Nab > Plac Prop > Act Cann
Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC)
Plac Nab > Plac Prop > Plac Cann
Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC)
Overall Study
STARTED
1
1
1
1
Overall Study
COMPLETED
1
1
0
0
Overall Study
NOT COMPLETED
0
0
1
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nabilone in Cannabis Users With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nabilone/Propranolol/Placebo + Smoked Cannabis/Placebo Placebo
n=2 Participants
Nabilone capsules (4 mg) Propranolol (40mg) Placebo (0mg nabilone or propranolol) Placebo cannabis (0.0% THC) Smoked cannabis (5.6% THC)
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
Sex: Female, Male
Male
2 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
Race (NIH/OMB)
White
0 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
2 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 1 month

Population: We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.

We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.

Outcome measures

Outcome data not reported

Adverse Events

Active Nab > Plac Prop > Plac Cann

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Plac Nab > Act Prop > Plac Cann

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Plac Nab > Plac Prop > Act Cann

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Plac Nab > Plac Prop > Plac Cann

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Haney, Ph.D.

New York State Psychiatric Institute

Phone: 646-774-6129

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place