Trial Outcomes & Findings for Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1 (NCT NCT00131456)

Last Updated: 2019-04-24

Results Overview

The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

measured daily by self report for 12 weeks of the trial or length of study participation

Results posted on

2019-04-24

Participant Flow

The study was conducted from January 2004 through September 2010. Treatment seekers for problems related to marijuana use were recruited by local advertising or clinical referrals. Participants were treated at Columbia University/New York State Psychiatric Institute or at Columbia University/North Shore-LIJ Medical Center.

The trial included a one-week placebo lead-in. Placebo responders during the placebo lead in (N = 7), defined as a Clinical Global Impression rating of 1 or 2 and a reduction in the Hamilton Depression score \> 75% or total score ≤ 7, were not randomized. Additionally, 13 participants were lost to follow-up so a total of 103 were randomized.

Participant milestones

Participant milestones
Measure	Placebo Matched Placebo	Venlafaxine Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
Overall Study STARTED	52	51
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	19	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=52 Participants Matched Placebo	Venlafaxine n=51 Participants Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.9 years STANDARD_DEVIATION 9.3 • n=5 Participants	34.2 years STANDARD_DEVIATION 10.8 • n=7 Participants	35.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: measured daily by self report for 12 weeks of the trial or length of study participation

Population: All analyses were conducted based on the intent-to-treat principle.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Matched Placebo	Venlafaxine n=51 Participants Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
Two Consecutive Weeks of Marijuana Abstinence	19 participants	6 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Venlafaxine

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=52 participants at risk Matched Placebo	Venlafaxine n=51 participants at risk Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
Psychiatric disorders anxiety	1.9% 1/52 • Number of events 1	11.8% 6/51 • Number of events 6
Gastrointestinal disorders diarrhea	5.8% 3/52 • Number of events 3	7.8% 4/51 • Number of events 4
General disorders dizziness	3.8% 2/52 • Number of events 2	15.7% 8/51 • Number of events 8
General disorders fatigue	1.9% 1/52 • Number of events 1	11.8% 6/51 • Number of events 6
Gastrointestinal disorders GI Upset	3.8% 2/52 • Number of events 2	11.8% 6/51 • Number of events 6
General disorders headache	7.7% 4/52 • Number of events 4	3.9% 2/51 • Number of events 2
General disorders insomnia	7.7% 4/52 • Number of events 4	13.7% 7/51 • Number of events 7
General disorders loss of libido	0.00% 0/52	11.8% 6/51 • Number of events 6
General disorders muscle aches	7.7% 4/52 • Number of events 4	3.9% 2/51 • Number of events 2
Gastrointestinal disorders nausea	7.7% 4/52 • Number of events 4	11.8% 6/51 • Number of events 6
General disorders syncopy or light headedness	7.7% 4/52 • Number of events 4	3.9% 2/51 • Number of events 2

Additional Information

Dr. Frances R. Levin

Columbia University

Phone: 212-543-5896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place