Clinical trial NCT03154580: Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users
Official title: Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users: A Pilot Test of Glutamatergic Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marijuana Abuse
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the proposed study is to examine the relationship between marijuana reminders, or "cues", craving for marijuana, and marijuana use. The principal investigator is also assessing whether N-acetylcysteine, can reduce marijuana craving or use.

Detailed description: This study involves three screening sessions that could last about 3 hours each.

Part of this study will be conducted on an inpatient unit where the participant will live for 4 straight nights.

During the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank). Participants will be asked to take capsules that could contain N-acetylcysteine or placebo (blank).

Participants will be asked to complete questionnaires and have vital signs (blood pressure, heart rate) monitored.

Participants will be asked to participate in overnight sleep recordings, a polysomnogram (PSG).

Eligibility criteria: Inclusion Criteria:

* Participants will be healthy individuals 21-55 year olds who use marijuana.
* Marijuana use will be verified by self-report and THC-positive urine samples. -Participants must meet DSM 5 criteria for Cannabis Use Disorder and be willing to participate in research but not seeking treatment.

Exclusion Criteria:

* Candidates with the following conditions will be excluded:
* Serious psychiatric illness (e.g. psychotic or bipolar disorder
* Recent (past 5 years) suicide attempts
* Major depression that is not substance-induced)
* Substance Use Disorders (SUD) other than Cannabis or Nicotine Use Disorders and Mild Alcohol Use Disorder
* Neurological diseases (e.g. stroke, seizures)
* Cardiovascular problems (e.g. myocardial infarction, angina, systolic BP \>160 or \<95 mmHg, diastolic BP \>95 mmHg, clinically abnormal ECG)
* Pulmonary diseases (e.g. asthma, TB)
* Systemic diseases (e.g. hepatitis, autoimmune, Cushing syndrome)
* Cognitive impairment (\<80 IQ)
* Past-month exposure to medications that increase study risk (e.g. toxicity to major organs, asthma inhalers)
* Women who are pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral/depot contraceptives, IUD, condom/foam, sterilization, tubal ligation)
* Seeking treatment for a Substance Use Disorder.
* Individuals unable to give voluntary informed consent will be excluded. Applicants interested in treatment will be excluded from the study and referred to a treatment program.

Primary outcomes:
measure: Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
timeFrame: Change is being assessed. Marijuana Craving VAS administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1250, 1310, 1320, 1330, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Marijuana Craving Questionnaire (Self-report measure)
timeFrame: Change is being assessed. Marijuana Craving Quest.administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Marijuana Rating Form (Self-report measure)
timeFrame: Change is being assessed. Marijuana Rating Form administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)
timeFrame: Change is being assessed. Subjective Effects Scale administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Questionnaire of Smoking Urges (Self-report measure)
timeFrame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Marijuana Withdrawal Checklist
timeFrame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: NAC Side Effect Checklist
timeFrame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Systolic blood pressure (physiological effects)
timeFrame: Change is being assessed. Systolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Diastolic blood pressure (physiological effects)
timeFrame: Change is being assessed. Diastolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Heart rate (physiological effects)
timeFrame: Change is being assessed. Heart rate measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
measure: Core-body temperature (physiological effects)
timeFrame: Change is being assessed. Core-body temperature measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Tolan Park Medical Building
state: Michigan
Study officials:
affiliation: Wane State University
name: Leslie Lundahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: