Brain Neurochemical Profile During Marijuana Abstinence

Completed

Conditions studied: Brain Metabolic Changes During Marijuana Abstinence

In brief

We have interviewed more than 120+ candidates and recruited 44 chronic marijuana users and 11 non-user healthy controls: 26 of the 44 MJ users actually participated in the study, 6 of the 26 MJ participants dropped out after their baseline magnetic resonance (MR) visits and the remaining 20 participants completed the study protocol, namely completed three MR visits for measurement of brain metabolites (baseline, day 7, and day 21); among the 11 healthy controls, 10 completed the study protocol. We are currently analyzing collected data and preparing manuscripts for peer reviewed journals.

Key facts

Study ID

NCT04320537

Run by

Mclean Hospital

People needed

37

Starts

2017-07-01

Expected to finish

2020-01-31

Last updated by the study team

2020-03-25

Who can join

Age: 21 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Participants must be 21-40 years of age. 2. Women must not be pregnant, planning to get pregnant, or lactating. 3. Individuals must meet criteria of chronic, heavy use of marijuana to be enrolled in the group of MJ-users. Namely, participants in this group may, but do not have to, meet DSM-5 criteria for cannabis use disorder based on the Structured Clinical Interview for DSM Disorders (SCID-5) and they have to have had at least one years of reported use of four out of seven days per week, or greater than 25 episodes per month. An "episode" is defined as an occasion of smoking separated by at least one hour from another "episode." 4. Participants must be able to comply with the study protocol, willing to remain abstinent during the 3-week period, willing to limit amounts of alcohol and tobacco consumption during the study period, and willing to commit the time to participate in the study. 5. Participants must be able to provide written informed consent. 6. Participants must be able and willing to complete questionnaires during various visits.

You may not qualify if…

• 1. Individuals with significant and symptomatic medical or neurological co-morbidity, such as chronic fatigue syndrome or fibromyalgia, or any current Axis I Psychiatric Disorder, severe medical conditions such as multiple sclerosis, anemia, cancer, cirrhosis, heart disease, or kidney disease, or history of head trauma resulting in loss of consciousness requiring hospital evaluation. 2. Individuals who have been on atypical antipsychotic medications, sleeping medications, or steroid/testosterone. 3. Individuals must not have been on stimulant medications or antidepressant medications including Selective Serotonin Reuptake Inhibitors (SSRIs), for at least one year. 4. Individuals must not currently hold a medical marijuana certificate. 5. Individuals who, in the Principal Investigator's judgment, will not likely be able to comply with the study protocol. 6. Individuals meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current substance use disorder other than MJ 7. Individuals who have any lifetime regular use of cocaine, stimulants, or hallucinogens more than twice monthly 8. Individuals who smoke more than 10 tobacco cigarettes daily 9. Individuals who consume more than two alcoholic drinks per day, on average, or report binge drinking (4 or more drinks for women, 5 or more drinks for men).
• In addition to the above criteria, the following exclusion criteria apply for subjects participating in this MR study:
• MR Exclusion Criteria:
• Contraindication to MR scanning, including claustrophobia.
• Individuals unable to comply with instructions or procedures of study.
• Presence of metal pins or braces in subject.
• Evidence of structural brain abnormalities on brain MRI. (Inclusion Criteria and Exclusion Criteria for the subjects including controls have been stated in above section D Research Design and Methods)

Where it is running

• Chun Zuo — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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