Trial Outcomes & Findings for Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence (NCT NCT01467999)

NCT ID: NCT01467999

Last Updated: 2019-02-05

Results Overview

The reduction in cannabis consumption quantified by the number of days of cannabis use per week was assessed, as measured by the Time Line followback, reported week 1 compared to week 8.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: Daily cannabis use reported during the 8 week trial or the length of the patient's participation
• Results posted on: 2019-02-05

Participant Flow

Participants responded to newspapers, radio and public service announcements in the New York City area, and reported at least 20 days of use in the past 30 days.

Participant milestones

Measure	Guanfacine Guanfacine, 4mg given once daily Guanfacine: Guanfacine, 4mg given once daily
Overall Study STARTED	22
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence

Baseline characteristics by cohort

Measure	Guanfacine n=22 Participants Guanfacine, 4mg given once daily Guanfacine: Guanfacine, 4mg given once daily
Age, Continuous	36.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 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	5 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Daily cannabis use reported during the 8 week trial or the length of the patient's participation

Population: intent-to-treat sample

The reduction in cannabis consumption quantified by the number of days of cannabis use per week was assessed, as measured by the Time Line followback, reported week 1 compared to week 8.

Outcome measures

Measure	Guanfacine n=22 Participants Guanfacine, 4mg given once daily Guanfacine: Guanfacine, 4mg given once daily
Reduction in Mean Number of Days of Cannabis Use Per Week week 1	4.1 days of use per week Standard Deviation 0.6
Reduction in Mean Number of Days of Cannabis Use Per Week week 8	3.1 days of use per week Standard Deviation 0.9

Adverse Events

Guanfacine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Guanfacine n=22 participants at risk Guanfacine, 4mg given once daily Guanfacine: Guanfacine, 4mg given once daily
Gastrointestinal disorders constipation	9.1% 2/22 • Number of events 2 • during 8 weeks of open label participation
General disorders drowsiness	13.6% 3/22 • Number of events 3 • during 8 weeks of open label participation
General disorders dry mouth	22.7% 5/22 • Number of events 5 • during 8 weeks of open label participation
General disorders fatigue	22.7% 5/22 • Number of events 5 • during 8 weeks of open label participation
General disorders headache	4.5% 1/22 • Number of events 1 • during 8 weeks of open label participation
Cardiac disorders hypotension	13.6% 3/22 • Number of events 3 • during 8 weeks of open label participation
General disorders increased urination	4.5% 1/22 • Number of events 1 • during 8 weeks of open label participation
General disorders insomnia	22.7% 5/22 • Number of events 5 • during 8 weeks of open label participation
General disorders lightheadedness	18.2% 4/22 • Number of events 4 • during 8 weeks of open label participation
Gastrointestinal disorders nausea	13.6% 3/22 • Number of events 3 • during 8 weeks of open label participation

Additional Information

daniel brooks

NYSPI

Phone: 6467746171

Email: daniel.brooks@nyspi.columbia.edu

Results disclosure agreements

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