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Completed

NCT Number: NCT03154580

Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

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.

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Key information

Conditions

Marijuana Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl cysteine

Drug

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

Primary outcomes

  1. Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)

    Time frame: 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.

  2. Marijuana Craving Questionnaire (Self-report measure)

    Time frame: Change is being assessed. Marijuana Craving Quest.administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  3. Marijuana Rating Form (Self-report measure)

    Time frame: Change is being assessed. Marijuana Rating Form administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  4. Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)

    Time frame: Change is being assessed. Subjective Effects Scale administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  5. Questionnaire of Smoking Urges (Self-report measure)

    Time frame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  6. Marijuana Withdrawal Checklist

    Time frame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  7. NAC Side Effect Checklist

    Time frame: Change is being assessed. Questionnaire is administered at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  8. Systolic blood pressure (physiological effects)

    Time frame: Change is being assessed. Systolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  9. Diastolic blood pressure (physiological effects)

    Time frame: Change is being assessed. Diastolic blood pressure measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  10. Heart rate (physiological effects)

    Time frame: Change is being assessed. Heart rate measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

  11. Core-body temperature (physiological effects)

    Time frame: Change is being assessed. Core-body temperature measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Acronym: MCN

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 16, 2017
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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