Cannabis Use
Conditions
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.
Interventions
DRUGLorcaserin
Lorcaserin 10mg BID
DRUGPlacebo
Placebo capsule BID
DRUGMarijuana
Smoked marijuana cigarette
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannabis Self-administration | 14 days | Number of cannabis puffs participant chooses to smoke. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lorcaserin + Marijuana Lorcaserin: Lorcaserin 10mg or 0mg BID
Marijuana: Smoked marijuana cigarette | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Lorcaserin + Marijuana |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 30.9 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 8 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Cannabis Self-administration
Number of cannabis puffs participant chooses to smoke.
Time frame: 14 days
Population: Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lorcaserin + Marijuana | Cannabis Self-administration | Cannabis relapse: choice of cannabis puffs following 3 days of abstinence | 5.75 puffs of cannabis chosen | Standard Error 1 |
| Lorcaserin + Marijuana | Cannabis Self-administration | Cannabis abstinence initiation: choice of cannabis puffs following 0 days of abstinence | 5.75 puffs of cannabis chosen | Standard Error 1 |
| Placebo + Marijuana | Cannabis Self-administration | Cannabis relapse: choice of cannabis puffs following 3 days of abstinence | 9.2 puffs of cannabis chosen | Standard Error 1 |
| Placebo + Marijuana | Cannabis Self-administration | Cannabis abstinence initiation: choice of cannabis puffs following 0 days of abstinence | 7.5 puffs of cannabis chosen | Standard Error 1 |