Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

July 25, 2022 updated by: Margaret Haney, New York State Psychiatric Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2017

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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