Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users (MCN)

Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users: A Pilot Test of Glutamatergic Modulation

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Abuse
• Intervention / Treatment: Drug: N-acetyl cysteine

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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Tolan Park Medical Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: N-acetylcysteine 0mg X Cue Exposure (neutral)	Drug: N-acetyl cysteine; Participants will receive 4 capsules at 11:15am on each experimental session day.
Placebo Comparator: N-acetylcysteine 0mg X Cue Exposure (marijuana)	Drug: N-acetyl cysteine; Participants will receive 4 capsules at 11:15am on each experimental session day.
Active Comparator: N-acetylcysteine 2400mg X Cue Exposure (neutral)	Drug: N-acetyl cysteine; Participants will receive 4 capsules at 11:15am on each experimental session day.
Active Comparator: N-acetylcysteine 2400mg X Cue Exposure (marijuana)	Drug: N-acetyl cysteine; Participants will receive 4 capsules at 11:15am on each experimental session day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)	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.
Marijuana Craving Questionnaire (Self-report measure)	Change is being assessed. Marijuana Craving Quest.administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Marijuana Rating Form (Self-report measure)	Change is being assessed. Marijuana Rating Form administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)	Change is being assessed. Subjective Effects Scale administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Questionnaire of Smoking Urges (Self-report measure)	Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Marijuana Withdrawal Checklist	Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
NAC Side Effect Checklist	Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Systolic blood pressure (physiological effects)	Change is being assessed. Systolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Diastolic blood pressure (physiological effects)	Change is being assessed. Diastolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Heart rate (physiological effects)	Change is being assessed. Heart rate measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Core-body temperature (physiological effects)	Change is being assessed. Core-body temperature measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Leslie Lundahl, PhD, Wane State University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: MCN-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No