Trial Outcomes & Findings for Facilitating the Behavioral Treatment of Cannabis Use Disorder (NCT NCT02946489)

Last Updated: 2020-02-11

Results Overview

Percentage of participants with cannabis abstinence or significant reduction in cannabis use by end of study. Significant reduction in cannabis use was defined as: At least 50% reduction in cannabis use between pre-infusion and end of 6 week study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

At Week 6 (End of study)

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	CI-581a+MET+MBRP Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Facilitating the Behavioral Treatment of Cannabis Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CI-581a+MET+MBRP n=8 Participants Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Age, Continuous	42.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 6 (End of study)

Outcome measures

Outcome measures
Measure	CI-581a+MET+MBRP n=8 Participants Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use	7 Participants

SECONDARY outcome

Timeframe: Change between pre-infusion and end of 6 week study

Change in confidence in abstaining from cannabis as measured by the DCQ (Drug-Taking Confidence Questionnaire). DCQ is a scale from 0 to 100, with higher values indicating greater confidence in one's ability to abstain from cannabis.

Outcome measures

Outcome measures
Measure	CI-581a+MET+MBRP n=8 Participants Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Confidence in Abstaining From Cannabis	42.8125 units on a scale Standard Deviation 27.56283

Adverse Events

CI-581a+MET+MBRP

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

Elias Dakwar, MD

New York State Psychiatric Institute

Phone: 6467748728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place