search
Back to results

Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

Primary Purpose

Cannabis Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo
Marijuana
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis Use

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin + Marijuana

Placebo + Marijuana

Arm Description

Outcomes

Primary Outcome Measures

Cannabis Self-administration
Number of cannabis puffs participant chooses to smoke.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2017
Last Updated
July 25, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03253926
Brief Title
Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Official Title
Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin + Marijuana
Arm Type
Experimental
Arm Title
Placebo + Marijuana
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Intervention Description
Lorcaserin 10mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule BID
Intervention Type
Drug
Intervention Name(s)
Marijuana
Intervention Description
Smoked marijuana cigarette
Primary Outcome Measure Information:
Title
Cannabis Self-administration
Description
Number of cannabis puffs participant chooses to smoke.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

We'll reach out to this number within 24 hrs