Marijuana AbusePhase 1MCNNCT03154580
Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users
A Phase 1 study testing N-acetyl cysteine in people with Marijuana Abuse, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 27 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
Official title: Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users: A Pilot Test of Glutamatergic Modulation
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.
Read the 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).
- Conditions
- Marijuana Abuse
- Being tested
- N-acetyl cysteine
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Participants will receive 4 capsules at 11:15am on each experimental session day.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine 0mg X Cue Exposure (neutral) | Placebo comparator | Not described Receives: Drug: N-acetyl cysteine |
| N-acetylcysteine 0mg X Cue Exposure (marijuana) | Placebo comparator | Not described Receives: Drug: N-acetyl cysteine |
| N-acetylcysteine 2400mg X Cue Exposure (neutral) | Active comparator | Not described Receives: Drug: N-acetyl cysteine |
| N-acetylcysteine 2400mg X Cue Exposure (marijuana) | Active comparator | Not described Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change is being assessed. Core-body temperature measured at baseline 0900, at 0930, 1000, 1030, 1100, 1230, 1345, 1400, 1430, 1500, 1530, and 1600.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 May 2017
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie Lundahl, PhD, Principal investigator, Wane State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154580
- Sponsor's protocol ID
- MCN-1
- Acronym
- MCN
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2017
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users: A Pilot Test of Glutamatergic Modulation
- ClinicalTrials.gov ID
- NCT03154580
- Acronym / sponsor ID
- MCN / MCN-1
- Conditions
- Marijuana Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine 0mg X Cue Exposure (neutral) | Placebo comparator | Drug: N-acetyl cysteine |
| N-acetylcysteine 0mg X Cue Exposure (marijuana) | Placebo comparator | Drug: N-acetyl cysteine |
| N-acetylcysteine 2400mg X Cue Exposure (neutral) | Active comparator | Drug: N-acetyl cysteine |
| N-acetylcysteine 2400mg X Cue Exposure (marijuana) | Active comparator | Drug: N-acetyl cysteine |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineParticipants will receive 4 capsules at 11:15am on each experimental session day. | Drug | N-acetylcysteine 0mg X Cue Exposure (marijuana), N-acetylcysteine 0mg X Cue Exposure (neutral), N-acetylcysteine 2400mg X Cue Exposure (marijuana), N-acetylcysteine 2400mg X Cue Exposure (neutral) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Lundahl, PhD principal investigator
Wane State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-acetyl cysteine in people with Marijuana Abuse, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.