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

Primary Purpose

Marijuana Abuse

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

N-acetyl cysteine

About this trial

This is an interventional basic science trial for Marijuana Abuse

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Tolan Park Medical Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

N-acetylcysteine 0mg X Cue Exposure (neutral)

N-acetylcysteine 0mg X Cue Exposure (marijuana)

N-acetylcysteine 2400mg X Cue Exposure (neutral)

N-acetylcysteine 2400mg X Cue Exposure (marijuana)

Arm Description

Outcomes

Primary Outcome Measures

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

Marijuana Craving Questionnaire (Self-report measure)

Marijuana Rating Form (Self-report measure)

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

Questionnaire of Smoking Urges (Self-report measure)

Marijuana Withdrawal Checklist

NAC Side Effect Checklist

Systolic blood pressure (physiological effects)

Diastolic blood pressure (physiological effects)

Heart rate (physiological effects)

Core-body temperature (physiological effects)

Secondary Outcome Measures

Full Information

NCT ID

NCT03154580

First Posted

April 25, 2017

Last Updated

February 23, 2022

Sponsor

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT03154580

Brief Title

Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

Acronym

MCN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

May 28, 2022 (Anticipated)

Study Completion Date

May 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Abuse

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine 0mg X Cue Exposure (neutral)

Arm Type

Placebo Comparator

Arm Title

N-acetylcysteine 0mg X Cue Exposure (marijuana)

Arm Type

Placebo Comparator

Arm Title

N-acetylcysteine 2400mg X Cue Exposure (neutral)

Arm Type

Active Comparator

Arm Title

N-acetylcysteine 2400mg X Cue Exposure (marijuana)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

N-acetyl cysteine

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leslie Lundahl, PhD

Organizational Affiliation

Wane State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tolan Park Medical Building

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users

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