Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

NCT03154580 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MCN-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Abuse

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (4)

N-acetylcysteine 0mg X Cue Exposure (neutral)

PLACEBO COMPARATOR

Drug: N-acetyl cysteine

N-acetylcysteine 0mg X Cue Exposure (marijuana)

PLACEBO COMPARATOR

Drug: N-acetyl cysteine

N-acetylcysteine 2400mg X Cue Exposure (neutral)

ACTIVE COMPARATOR

Drug: N-acetyl cysteine

N-acetylcysteine 2400mg X Cue Exposure (marijuana)

ACTIVE COMPARATOR

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteine DRUG

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

N-acetylcysteine 0mg X Cue Exposure (marijuana); N-acetylcysteine 0mg X Cue Exposure (neutral); N-acetylcysteine 2400mg X Cue Exposure (marijuana); N-acetylcysteine 2400mg X Cue Exposure (neutral)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Leslie Lundahl, PhD

  Wane State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 16, 2017
• Study Start: May 1, 2017
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)