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Trial record 2 of 153 for:    Recruiting, Not yet recruiting, Available Studies | "Marijuana Abuse"

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

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ClinicalTrials.gov Identifier: NCT03154580
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154580


Contacts
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Contact: Alina Woodford 313-993-3960 awoodford@med.wayne.edu

Locations
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United States, Michigan
Tolan Park Medical Building Recruiting
Detroit, Michigan, United States, 48201
Contact: Leslie Lundahl, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Leslie Lundahl, PhD Wane State University

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Responsible Party: Leslie Lundahl, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT03154580     History of Changes
Other Study ID Numbers: MCN-1
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes