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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Contraindication to MR scanning, including claustrophobia.
  2. Individuals unable to comply with instructions or procedures of study.
  3. Presence of metal pins or braces in subject.
  4. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: abstinence from use of marijuana and other abused drugs
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
Other: abstinence from use of marijuana and other abused drugs
abstinence from use of marijuana use and other abused drugs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mclean Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Scott E. Lukas, PhD, McLean Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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