Cannabis UsePhase 1/2NCT03253926

Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

A Phase 1/2 study testing Lorcaserin and Marijuana in people with Cannabis Use, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis Use
What is being tested?: Lorcaserin and Marijuana
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2017to 31 Dec 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Current cannabis use
Able to give informed consent and perform study procedures
Women practicing an effective form of birth control
English speaking

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

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

Read the 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.

Conditions: Cannabis Use
Being tested: Lorcaserin, Placebo, Marijuana

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LorcaserinDrug
Lorcaserin 10mg BID
PlaceboDrug
Placebo capsule BID
MarijuanaDrug
Smoked marijuana cigarette

Study groups in NCT03253926
Study group	Role	What they receive
Lorcaserin + Marijuana	Experimental	Not described Receives: Drug: Lorcaserin; Drug: Marijuana
Placebo + Marijuana	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Marijuana

What is being measured

The primary outcome is the main question the study is designed to answer.

Cannabis Self-administration
Number of cannabis puffs participant chooses to smoke.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201731 Dec 2021

First posted18 Aug 2017
Study start5 Sep 2017
Primary completion31 May 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cannabis UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03253926
Sponsor's protocol ID: 7475
Status last verified: Jul 2022
First submitted: 14 Aug 2017
Last updated: 26 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
ClinicalTrials.gov ID: NCT03253926
Acronym / sponsor ID: 7475
Conditions: Cannabis Use
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Sep 2017 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 18 Aug 2017 (actual)
Results: Posted 26 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lorcaserin + Marijuana	Experimental	Drug: Lorcaserin, Drug: Marijuana
Placebo + Marijuana	Placebo comparator	Drug: Placebo, Drug: Marijuana

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Current cannabis use
Able to give informed consent and perform study procedures
Women practicing an effective form of birth control
English speaking

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LorcaserinLorcaserin 10mg BID	Drug	Lorcaserin + Marijuana
PlaceboPlacebo capsule BID	Drug	Placebo + Marijuana
MarijuanaSmoked marijuana cigarette	Drug	Lorcaserin + Marijuana, Placebo + Marijuana

Primary outcome

Cannabis Self-administration
Time frame: 14 days
Number of cannabis puffs participant chooses to smoke.

Results and safety

Results posted to the registry on 26 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lorcaserin + Marijuana First, Then Placebo + Marijuana	7	7
Placebo + Marijuana First, Then Lorcaserin + Marijuana	8	8

Primary outcome: Cannabis Self-administration

Time frame: 14 days. Mean (Standard Error). Unit: puffs of cannabis chosen

Measure	Lorcaserin + Marijuana n = 15	Placebo + Marijuana n = 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)

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

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lorcaserin + Marijuana	0 of 15 (0%)	15 of 15 (100%)	0 of 15
Placebo + Marijuana	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lorcaserin and Marijuana in people with Cannabis Use, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cannabis Self-administration (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03253926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.