A Phase 1/2 interventional study of Lorcaserin and Placebo in Cannabis Use, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Basic science
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In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.
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.
New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lorcaserin · Drug: Marijuana
Drug: Placebo · Drug: Marijuana
Lorcaserin 10mg BID
Placebo capsule BID
Smoked marijuana cigarette
Cannabis Self-administration
Number of cannabis puffs participant chooses to smoke.
Time frame: 14 days
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.
| Milestone | Lorcaserin + Marijuana First, Then Placebo + Marijuana | Placebo + Marijuana First, Then Lorcaserin + Marijuana |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
Number of cannabis puffs participant chooses to smoke.
| puffs of cannabis chosen | Lorcaserin + Marijuana | Placebo + Marijuana |
|---|---|---|
| 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 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lorcaserin + Marijuana | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Placebo + Marijuana | 0/15 (0%) | 0/15 (0%) | 8/15 (53.3%) |
| Event | Lorcaserin + Marijuana | Placebo + Marijuana |
|---|---|---|
| Gastrointestinal upsetProduct Issues | 6/15 | 4/15 |
| HeadacheProduct Issues | 3/15 | 1/15 |
| Eye dryness/discomfortProduct Issues | 2/15 | 1/15 |
| Trouble sleepingProduct Issues | 2/15 | 0/15 |
| Body painProduct Issues | 1/15 | 1/15 |
| Anxiety/JitteryProduct Issues | 1/15 | 1/15 |
| Age, Categorical(Participants) | Lorcaserin + Marijuana |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Lorcaserin + Marijuana |
|---|---|
| Mean | 30.9 ± 7.7 |
| Sex: Female, Male(Participants) | Lorcaserin + Marijuana |
|---|---|
| Female | 4 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Lorcaserin + Marijuana |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Lorcaserin + Marijuana |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 2 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Lorcaserin + Marijuana |
|---|---|
| United States | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in May 2021, 44 months.
Results were first posted in Jul 2022, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Lorcaserin
New York State Psychiatric Institute →