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Trial Outcomes & Findings for Effect of Quetiapine on Marijuana Withdrawal and Relapse (NCT NCT00743366)

NCT ID: NCT00743366

Last Updated: 2017-08-18

Results Overview

This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

Results posted on

2017-08-18

Participant Flow

14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.

Participant milestones

Participant milestones
Measure
Quetiapine (200mg/Day), Placebo
Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
Placebo, Quetiapine (200mg/Day)
Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
Intervention 1 (8 Days)
STARTED
10
10
Intervention 1 (8 Days)
COMPLETED
7
7
Intervention 1 (8 Days)
NOT COMPLETED
3
3
Intervention 2 (8 Days)
STARTED
7
7
Intervention 2 (8 Days)
COMPLETED
7
7
Intervention 2 (8 Days)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Quetiapine (200mg/Day), Placebo
Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
Placebo, Quetiapine (200mg/Day)
Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
Intervention 1 (8 Days)
Withdrawal by Subject
3
3

Baseline Characteristics

Effect of Quetiapine on Marijuana Withdrawal and Relapse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Number of Baseline Participants
n=14 Participants
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Age, Continuous
26 years
STANDARD_DEVIATION 4 • n=99 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
Region of Enrollment
United States
14 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.

Outcome measures

Outcome measures
Measure
Quetiapine, Marijuana
n=14 Participants
quetiapine's effects on marijuana withdrawal and relapse Marijuana: 0,6.9% THC Quetiapine: 0, 200 mg/day
Placebo, Marijuana
n=14 Participants
Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
2.5 Puffs
Standard Error 0.6
1.5 Puffs
Standard Error 1.1

Adverse Events

Quetiapine (200mg/Day), Placebo

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo, Quetiapine (200mg/Day)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Quetiapine (200mg/Day), Placebo
n=20 participants at risk
Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
Placebo, Quetiapine (200mg/Day)
n=20 participants at risk
Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
Gastrointestinal disorders
gastrointestinal discomfort
10.0%
2/20 • Number of events 2
5.0%
1/20 • Number of events 1

Additional Information

Dr. Ziva Cooper

New York State Psychiatric Institute

Phone: 646-774-6129

Results disclosure agreements

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