Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03253926
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 51.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use	Drug: Lorcaserin; Drug: Placebo; Drug: Marijuana	Phase 1/Phase 2

Detailed Description

In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have developed a laboratory model to investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non treatment-seeking cannabis smokers. In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
• Actual Study Start Date: Sep 5, 2017
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin + Marijuana	Drug: Lorcaserin; Lorcaserin 10mg BID; Drug: Marijuana; Smoked marijuana cigarette
Placebo Comparator: Placebo + Marijuana	Drug: Placebo; Placebo capsule BID; Drug: Marijuana; Smoked marijuana cigarette

Outcome Measures

Primary Outcome Measures

1. Cannabis Self-administration [14 days]

   Number of cannabis puffs participant chooses to smoke.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Current cannabis use

• Able to give informed consent and perform study procedures

• Women practicing an effective form of birth control

• English speaking

Exclusion Criteria:

• Presence of any clinically significant medical diagnoses

• History of heart disease and cardiac risk factors, severe chronic obstructive pulmonary disease, uncontrolled hypertension, or diabetes

• Current parole or probation

• Certain psychiatric diagnoses

• Current pregnancy or lactation

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
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 12, 2018
• Statistical Analysis Plan - Jun 29, 2022
• Informed Consent Form - Aug 9, 2017

More Information

Publications

None provided.

• Responsible Party: Margaret Haney, Professor of Neurobiology (in Psychiatry) at CUMC, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03253926
• Other Study ID Numbers: 7475
• First Posted: Aug 18, 2017
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Marijuana Abuse

Study Results

Participant Flow

Recruitment Details

Participants were enrolled in this study comprising two 13-day inpatient phases, each of which was preceded by two medication administration outpatient days to achieve steady-state levels prior to key behavioral measures. Each phase tested a different medication condition (lorcaserin 10 mg or placebo BID) in a within-subject design, with at least one medication-free week between phases to allow for medication clearance.

Arm/Group Title	Lorcaserin + Marijuana First, Then Placebo + Marijuana	Placebo + Marijuana First, Then Lorcaserin + Marijuana
Arm/Group Description	Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette	Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette
Period Title: Overall Study
STARTED	7	8
COMPLETED	7	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lorcaserin + Marijuana
Arm/Group Description	Lorcaserin: Lorcaserin 10mg or 0mg BID Marijuana: Smoked marijuana cigarette
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (7.7)
Sex: Female, Male (Count of Participants)
Female	4 26.7%
Male	11 73.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 40%
Not Hispanic or Latino	9 60%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 13.3%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	10 66.7%
White	2 13.3%
More than one race	1 6.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Cannabis Self-administration
Description	Number of cannabis puffs participant chooses to smoke.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions.

Arm/Group Title	Lorcaserin + Marijuana	Placebo + Marijuana
Arm/Group Description	Lorcaserin: Lorcaserin 10mg BID Marijuana: Smoked marijuana cigarette	Placebo: Placebo capsule BID Marijuana: Smoked marijuana cigarette
Measure Participants	15	15
Cannabis relapse: choice of cannabis puffs following 3 days of abstinence	5.75 (1)	9.2 (1)
Cannabis abstinence initiation: choice of cannabis puffs following 0 days of abstinence	5.75 (1)	7.5 (1)

Adverse Events

Time Frame	Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
Arm/Group Title	Lorcaserin + Marijuana		Placebo + Marijuana
Arm/Group Description	Lorcaserin: Lorcaserin 10mg BID Marijuana: Smoked marijuana cigarette		Placebo: Placebo capsule BID Marijuana: Smoked marijuana cigarette
All Cause Mortality
	Lorcaserin + Marijuana		Placebo + Marijuana
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Lorcaserin + Marijuana		Placebo + Marijuana
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Lorcaserin + Marijuana		Placebo + Marijuana
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/15 (100%)		8/15 (53.3%)
Product Issues
Headache	3/15 (20%)	5	1/15 (6.7%)	1
Gastrointestinal upset	6/15 (40%)	11	4/15 (26.7%)	4
Body pain	1/15 (6.7%)	1	1/15 (6.7%)	1
Anxiety/Jittery	1/15 (6.7%)	1	1/15 (6.7%)	1
Eye dryness/discomfort	2/15 (13.3%)	4	1/15 (6.7%)	1
Trouble sleeping	2/15 (13.3%)	2	0/15 (0%)	0

Limitations/Caveats

There are several limitations to consider in the current study. First, given the study length, only one dose of lorcaserin was tested, though it was the FDA-approved therapeutic dose for obesity and the dose shown to reduce tobacco cigarette use in a clinical study targeting this population. Second, the sample comprised mostly men, limiting the generalizability of our conclusions.

More Information

Certain Agreements

All Principal Investigators ARE 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.