Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

Marijuana Abuse Clinical Trial

— MCN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154580
• Other study ID #: MCN-1
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2017
• Est. completion date: June 27, 2023

Study information

• Verified date: April 2024
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Drug:
• N-acetyl cysteine
Participants will receive 4 capsules at 11:15am on each experimental session day.

Locations

Country	Name	City	State
United States	Tolan Park Medical Building	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.