- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320537
Brain Neurochemical Profile During Marijuana Abstinence
March 24, 2020 updated by: Chun S. Zuo, Mclean Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Marijuana (MJ) is the most widely used illicit drug in the US among young adults.
A majority of those who enter treatment for MJ dependence relapse.
However, the mechanism of action of MJ on brain neurochemistry, especially in connection with the reported withdrawal symptoms, is still not well understood.
We hypothesized that brain gamma aminobutyric acid (GABA) and glutamate (glu) fluctuate during the transition between active exposure, early abstinence (1-2 days since last use), and prolonged abstinence (7 days and more), and an imbalance of GABA and glu during MJ abstinence was the metabolic source of the aforementioned withdrawal symptoms that make MJ abstinence so difficult for many individuals.
The investigator's specific aims were to measure MJ abstinence related changes in levels of GABA and glu and to correlate the changes in GABA and glu with MJ withdrawal symptoms and clinical measures at baseline, day 7, and day 21 into abstinence.
The MR measures were conducted at 3 tesla and the abstinence was verified by urinary tetrahydrocannabinol (THC) levels.
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- Chun Zuo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants were recruited without regard to sex, race, or ethnicity.
Based on prior research studies at McLean Hospital, in the northwest suburbs of Boston, we expect the number of men and women to be approximately equal, and about 5-15% of subjects to be African-American or Hispanic.
Overall, these distributions are not very different from the population statistics for the Greater Boston Area of 82.6% White, 8.3% African American, 6.3% Asian, and 2.8% of other ethnic or racial backgrounds based on 2014 census.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MJ user
non-treatment-seeking chronic heavy marijuana (MJ) users of both sexes and all ethnicities between the ages of 21-40 years who are willing to follow the study protocol and abstinence from marijuana for three weeks
|
abstinence from use of marijuana use and other abused drugs
|
Control
age- and sex-matched healthy control participants who are willing to follow the study protocol and remain in the study for three weeks
|
abstinence from use of marijuana use and other abused drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain Neurochemical Profile during Marijuana Abstinence
Time Frame: three weeks
|
brain metabolites correlated with withdrawal symptoms
|
three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
March 22, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P001508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Will follow NIH policy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Metabolic Changes During Marijuana Abstinence
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedCerebral Hypoxia During and/or Resulting From A Procedure
-
Université de SherbrookeFonds de la Recherche en Santé du Québec; Diabetes QuébecCompletedGestational Diabetes | Excessive Weight Gain During PregnancyCanada
-
University of PennsylvaniaCompletedThe IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes (IBEP)Gestational Diabetes | Weight Gain During Pregnancy | Weight Loss After PregnancyUnited States
-
Boston Children's HospitalBeth Israel Deaconess Medical Center; Winchester HospitalTerminatedHypoglycemia | Hypoxic-Ischemic Encephalopathy | Neonatal Abstinence SyndromeUnited States
-
Jens Rikardt AndersenAugustinus Fonden; Københavns Universitet; Familien Hede Nielsens FondWithdrawnMortality | Cannabis | Cachexia; Cancer | Morbidity | Neoplasms Pancreatic | Palliative Medicine | Appetite LossDenmark
-
Uta Lichter-KoneckiMedical College of Wisconsin; Children's National Research InstituteCompletedUrea Cycle Disorders | Organic AcidemiasUnited States
-
Beth Israel Deaconess Medical CenterCompletedDiabetes | Weight Loss | Hunger | Effects of Liraglutide Administration on Brain ActivityUnited States
-
National Taiwan University HospitalCompletedPostural and Suprapostural Performance During Dual Tasking in Patients With Parkinson's DiseaseTaiwan
-
The Miriam HospitalNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
Stanford UniversityCompletedObesity | Schizophrenia | Metabolic Syndrome | Bipolar Disorder | Weight Gain | Ketogenic Dieting | Psychotropic Agents Causing Adverse Effects in Therapeutic Use | Brain Metabolic DisorderUnited States
Clinical Trials on abstinence from use of marijuana and other abused drugs
-
University of VermontNational Cancer Institute (NCI)CompletedSubstance Withdrawal SyndromeUnited States
-
Philip Morris Products S.A.RecruitingSmoking | Tobacco Use | COPDUnited States, Bulgaria, Czechia, Germany, Japan, Romania, Slovakia, United Kingdom
-
Mayo ClinicCompletedSmokingUnited States
-
Azienda Ospedaliera di PadovaCompletedChronic HCV-related Hepatitis
-
Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Duke UniversityCompletedNicotine AddictionUnited States
-
University of California, San DiegoCenter for Medicinal Cannabis ResearchRecruitingHIV | Cannabis UseUnited States
-
Duke UniversityCompleted
-
Barth WilseyNational Institute on Drug Abuse (NIDA); University of California, San Diego; VA Northern California Health Care SystemCompletedSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Universidade PositivoCompletedMalocclusion | Orthodontic Appliance ComplicationBrazil