Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

NCT ID: NCT03154580

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2023-06-27

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).

Conditions

Marijuana Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

N-acetylcysteine 0mg X Cue Exposure (neutral)

Group Type: PLACEBO_COMPARATOR

N-acetyl cysteine

Intervention Type: DRUG

Participants will receive 4 capsules at 11:15am on each experimental session day.

N-acetylcysteine 0mg X Cue Exposure (marijuana)

Group Type: PLACEBO_COMPARATOR

N-acetyl cysteine

Intervention Type: DRUG

Participants will receive 4 capsules at 11:15am on each experimental session day.

N-acetylcysteine 2400mg X Cue Exposure (neutral)

Group Type: ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type: DRUG

Participants will receive 4 capsules at 11:15am on each experimental session day.

N-acetylcysteine 2400mg X Cue Exposure (marijuana)

Group Type: ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type: DRUG

Participants will receive 4 capsules at 11:15am on each experimental session day.

Interventions

N-acetyl cysteine

Participants will receive 4 capsules at 11:15am on each experimental session day.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Leslie Lundahl

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leslie Lundahl, PhD

Role: PRINCIPAL_INVESTIGATOR

Wane State University

Locations

Tolan Park Medical Building

Detroit, Michigan, United States

Countries

United States

Other Identifiers

MCN-1

Identifier Type: -

Identifier Source: org_study_id