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Trial record 18 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

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ClinicalTrials.gov Identifier: NCT03253926
Recruitment Status : Active, not recruiting
First Posted : August 18, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 5, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Lorcaserin

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




Primary Outcome Measures :
  1. Cannabis self-administration [ Time Frame: 14 days ]
    Number of cannabis cigarettes participant chooses to smoke.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253926


Locations
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United States, New York
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)

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Responsible Party: Margaret Haney, Professor of Neurobiology (in Psychiatry) at CUMC, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03253926     History of Changes
Other Study ID Numbers: 7475
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders