Effect of Quetiapine on Marijuana Withdrawal and Relapse

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00743366
• Collaborator: Research Foundation for Mental Hygiene, Inc. (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Smoking	Drug: Marijuana; Drug: Quetiapine; Drug: Placebo oral capsule	Phase 2

Detailed Description

The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effect of Quetiapine on Marijuana Withdrawal and Relapse
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine (200mg/day), Marijuana (6.2%, 0.0%) 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). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.	Drug: Marijuana; 0,6.2% THC; Other Names: cannabis ; Drug: Quetiapine; 200 mg/day; Other Names: seroquel
Placebo Comparator: Placebo, Marijuana (6.2%, 0.0%) Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.	Drug: Marijuana; 0,6.2% THC; Other Names: cannabis ; Drug: Placebo oral capsule; Other Names: Riboflavin

Outcome Measures

Primary Outcome Measures

1. Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks

• Able to perform study procedures

• 21-45 years of age

• Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD)

• Normal body weight

Exclusion Criteria:

• Current, repeated illicit drug use (other than marijuana)

• Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities)

• History of heart disease or current conduction system disease as indicated by QRS duration > 0.11

• Request for drug treatment

• Current parole or probation

• Pregnancy or current lactation

• Recent history of significant violent behavior

• Major current Axis I psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia)

• Current use of any prescription or over-the-counter medication

• Prior allergic or otherwise serious adverse reaction to quetiapine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Research Foundation for Mental Hygiene, Inc.
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Margaret Haney, Ph.D, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00743366
• Other Study ID Numbers: 5685; 5P50DA009236
• First Posted: Aug 28, 2008
• Last Update Posted: Aug 18, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by New York State Psychiatric Institute: quetiapine; smoked marijuana; marijuana use
• Additional relevant MeSH terms: Marijuana Abuse; Marijuana Use; Riboflavin; Quetiapine Fumarate

Study Results

Participant Flow

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

Arm/Group Title	Quetiapine (200mg/Day), Placebo	Placebo, Quetiapine (200mg/Day)
Arm/Group Description	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 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).
Period Title: Intervention 1 (8 Days)
STARTED	10	10
COMPLETED	7	7
NOT COMPLETED	3	3
Period Title: Intervention 1 (8 Days)
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Number of Baseline Participants
Arm/Group Description
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (4)
Sex: Female, Male (Count of Participants)
Female	2 14.3%
Male	12 85.7%
Region of Enrollment (Count of Participants)
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
Description	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.
Time Frame	Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quetiapine, Marijuana	Placebo, Marijuana
Arm/Group Description	quetiapine's effects on marijuana withdrawal and relapse Marijuana: 0,6.9% THC Quetiapine: 0, 200 mg/day
Measure Participants	14	14
Mean (Standard Error) [Puffs]	2.5 (0.6)	1.5 (1.1)

Adverse Events

Arm/Group Title	Quetiapine (200mg/Day), Placebo		Placebo, Quetiapine (200mg/Day)
Arm/Group Description	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 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).
All Cause Mortality
	Quetiapine (200mg/Day), Placebo		Placebo, Quetiapine (200mg/Day)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Quetiapine (200mg/Day), Placebo		Placebo, Quetiapine (200mg/Day)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Quetiapine (200mg/Day), Placebo		Placebo, Quetiapine (200mg/Day)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		1/20 (5%)
Gastrointestinal disorders
gastrointestinal discomfort	2/20 (10%)	2	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.