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

Sponsor

Wayne State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03154580

Collaborator

(none)

Enrollment

Location

Arms

60.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Abuse	Drug: N-acetyl cysteine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

May 28, 2022

Anticipated Study Completion Date :

May 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tolan Park Medical Building	Detroit	Michigan	United States	48201

Sponsors and Collaborators

Wayne State University

Investigators

Principal Investigator: Leslie Lundahl, PhD, Wane State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leslie Lundahl, Principal Investigator, Wayne State University

ClinicalTrials.gov Identifier:

NCT03154580

Other Study ID Numbers:

MCN-1

First Posted:

May 16, 2017

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Marijuana Abuse

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Feb 25, 2022