Study Focuses on Brain Morphology and Cognition in Older SubjectsCANNCT01874886
Cannabis Effects on Brain Morphology in Aging
An observational study of Study Focuses on Brain Morphology and Cognition in Older Subjects, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4 million Americans reporting past month use in 2010 and 4.6 million meeting criteria for dependence, underscoring the public health importance of understanding the biological implications of use. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Study Focuses on Brain Morphology and Cognition in Older Subjects
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2019
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be a community sample within the Los Angeles area. They will be recruited from the greater Los Angeles area using flyer postings in various areas of Los Angeles. Also, flyers will be posted in the Alzheimer's Disease Research Center at UCLA and the Longevity Center at UCLA as well as across the UCLA campus.
Who may be able to join
- Subjects will be 60 heavy users or non-users between 60-80 years of age
- Participants who used marijuana during adolescence. Current marijuana usage not allowed and subjects must complete urine screening at the time of inclusion.
Who cannot join
- Major psychiatric disorders, such bipolar disorder or schizophrenia as revealed by the Structured Clinical Interview for DSM-IV Disorders (100) and exclude for confounding psychiatric conditions
- Evidence of untreated depression as determined by a HAM-D Score of >12 (17-item version) or untreated anxiety by a score of > 8 on the Hamilton Anxiety Scale
- Evidence of neurologic or other physical illness that could produce cognitive deterioration.
- Volunteers with a history of TIAs, carotid bruits, or lacunae on MRI scan will be excluded
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)
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- History of significant liver disease
- Clinically significant pulmonary disease, diabetes, or cancer
- Because medications can affect cognitive functioning, subjects needing medicines that could influence psychometric test results will be excluded. These include: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, systemic corticosteroids, benzodiazepines, medications with significant cholinergic or anticholinergic effects, anticonvulsants, or warfarin, and any affecting the serotonin system, which may affect neuropsychological test results.
- Current diagnosis or history of alcoholism or dependence on any illicit drugs other than marijuana.
- Use of any investigational drugs within the previous month or longer, depending on drug half-life.
- Contraindication for MRI scan (e.g. metal in body, claustrophobia).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel/Resnick Neuropsychiatric Institute
Los Angeles, California, 90095
About this study
Official title: Effects of Heavy Adolescent Cannabis Use on Brain Morphology in Aging
Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4 million Americans reporting past month use in 2010 and 4.6 million meeting criteria for dependence, underscoring the public health importance of understanding the biological implications of use. How heavy cannabis use affects brain structure and cognitive performance in late life is unknown. The ongoing maturation in the adolescent brain, including the developmental circuitry underlying memory performance and executive control puts the adolescent brain at high risk for detrimental effects of heavy cannabis use. With the aging of the 'baby boomer' generation, many people who used cannabis heavily as adolescents are now entering their senior years when age-related cognitive decline may begin. Cannabis use doubled in less than a decade during the 1970's when 38% of those surveyed in the U.S. Survey on Drug Abuse reported using cannabis and 12% of those users reported using cannabis more than 20 times a month. Understanding how heavy, early cannabis use may affect neurobiological and cognitive outcomes is of high importance for this aging population, which is already at risk for memory and cognitive deficits in aging. Because cannabis use appears to have a primary effect within the hippocampus, the main structure for memory and the structure affected most by age-related memory impairments and pre-clinical Alzheimer's disease, we expect that the effects of chronic cannabis use may be greatest during aging. To our knowledge, no study has investigated the long-term effects of adolescent cannabis use on hippocampal morphology and cognitive performance in an aging population.
Investigators will investigate hippocampal integrity and cognitive performance using high-resolution magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and neuropsychological testing in an aging population of subjects (55-70 years old) who used cannabis more than 20 times a month for at least a year during adolescence. Investigators will compare data collected from heavy cannabis users to subjects who did not use cannabis but are matched for age, gender, education, light tobacco and light alcohol use. Finally, because family history and genetic risk are known to accelerate hippocampal morphology and memory decline in aging, the investigators will investigate whether possession of the APOE ε4 variant in heavy cannabis users is synergistically related to thinner hippocampal cortex and white matter deficits.
- Keywords
- Magnetic resonance imaging, Diffusion tensor imaging, Hippocampus, Cannabis, Geriatrics, Neuropsychology, Apolipoprotein E
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis users | ⋄Heavy Marijuana Users : 60-80 years old; Marijuana use initiated in adolescence with marijuana use of no more than 1-2 x/month after 30 years of age; Used marijuana more than 20 times/month for at least 1 year during this period. Cigarette smoking (tobacco) and alcohol will be allowed in both groups, which will be matched on number of smokers and nicotine dependence, measured according to the Fagerstrőm Test for Nicotine Dependence. Light alcohol use will also be allowed in and matched across both groups (< 14 drinks/week for men; < 7 drinks/week for women; may not meet DSM-IV criteria for alcohol dependence). | |
| Clean or Non-Users | ⋄No marijuana use, may smoke cigarettes, fewer than 7 drinks/week (women) or 14 drinks/week (men). 60-80 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance imaging of hippocampal size
Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with high resolution MRI to assess subtle MTL morphology.
Measured: Participants will complete an MRI scan which will take approximately 1 hour
Diffusion tensor imaging (DTI) to investigate white matter structure
Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with HARDI-DTI to investigate white matter structure.
Measured: Participants will complete an MRI scan with DTI sequence which will take approximately 1 hour
Cognitive performance in a range of neuropsychological tests
Investigators will use neuropsychological testing to assess episodic encoding and delayed memory performance. Investigators will also investigate whether any long-term cognitive deficits relate to gray matter or white matter deficits.
Measured: Neuropsychological testing will take approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study Focuses on Brain Morphology and Cognition in Older SubjectsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alison Burggren, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874886
- Sponsor's protocol ID
- 431587-AZ-29944
- Other IDs
- 1K01DA034728-01
- Acronym
- CAN
- Status last verified
- Nov 2020
- First submitted
- 3 Jun 2013
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Burggren AC, Siddarth P, Mahmood Z, London ED, Harrison TM, Merrill DA, Small GW, Bookheimer SY. Subregional Hippocampal Thickness Abnormalities in Older Adults with a History of Heavy Cannabis Use. Cannabis Cannabinoid Res. 2018 Dec 10;3(1):242-251. doi: 10.1089/can.2018.0035. eCollection 2018.
PubMed 30547094
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heavy Adolescent Cannabis Use on Brain Morphology in Aging
- ClinicalTrials.gov ID
- NCT01874886
- Acronym / sponsor ID
- CAN / 431587-AZ-29944
- Keywords
- Magnetic resonance imaging, Diffusion tensor imaging, Hippocampus, Cannabis, Geriatrics, Neuropsychology, Apolipoprotein E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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.
Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4 million Americans reporting past month use in 2010 and 4.6 million meeting criteria for dependence, underscoring the public health importance of understanding the biological implications of use. How heavy cannabis use affects brain structure and cognitive performance in late life is unknown. The ongoing maturation in the adolescent brain, including the developmental circuitry underlying memory performance and executive control puts the adolescent brain at high risk for detrimental effects of heavy cannabis use. With the aging of the 'baby boomer' generation, many people who used cannabis heavily as adolescents are now entering their senior years when age-related cognitive decline may begin. Cannabis use doubled in less than a decade during the 1970's when 38% of those surveyed in the U.S. Survey on Drug Abuse reported using cannabis and 12% of those users reported using cannabis more than 20 times a month. Understanding how heavy, early cannabis use may affect neurobiological and cognitive outcomes is of high importance for this aging population, which is already at risk for memory and cognitive deficits in aging. Because cannabis use appears to have a primary effect within the hippocampus, the main structure for memory and the structure affected most by age-related memory impairments and pre-clinical Alzheimer's disease, we expect that the effects of chronic cannabis use may be greatest during aging. To our knowledge, no study has investigated the long-term effects of adolescent cannabis use on hippocampal morphology and cognitive performance in an aging population.
Investigators will investigate hippocampal integrity and cognitive performance using high-resolution magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and neuropsychological testing in an aging population of subjects (55-70 years old) who used cannabis more than 20 times a month for at least a year during adolescence. Investigators will compare data collected from heavy cannabis users to subjects who did not use cannabis but are matched for age, gender, education, light tobacco and light alcohol use. Finally, because family history and genetic risk are known to accelerate hippocampal morphology and memory decline in aging, the investigators will investigate whether possession of the APOE ε4 variant in heavy cannabis users is synergistically related to thinner hippocampal cortex and white matter deficits.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis users | – | –⋄Heavy Marijuana Users : 60-80 years old; Marijuana use initiated in adolescence with marijuana use of no more than 1-2 x/month after 30 years of age; Used marijuana more than 20 times/month for at least 1 year during this period. Cigarette smoking (tobacco) and alcohol will be allowed in both groups, which will be matched on number of smokers and nicotine dependence, measured according to the Fagerstrőm Test for Nicotine Dependence. Light alcohol use will also be allowed in and matched across both groups (< 14 drinks/week for men; < 7 drinks/week for women; may not meet DSM-IV criteria for alcohol dependence). |
| Clean or Non-Users | – | –⋄No marijuana use, may smoke cigarettes, fewer than 7 drinks/week (women) or 14 drinks/week (men). 60-80 years old. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be a community sample within the Los Angeles area. They will be recruited from the greater Los Angeles area using flyer postings in various areas of Los Angeles. Also, flyers will be posted in the Alzheimer's Disease Research Center at UCLA and the Longevity Center at UCLA as well as across the UCLA campus.
Key inclusion criteria (2 listed)
- Subjects will be 60 heavy users or non-users between 60-80 years of age
- Participants who used marijuana during adolescence. Current marijuana usage not allowed and subjects must complete urine screening at the time of inclusion.
Key exclusion criteria (12 listed)
- Major psychiatric disorders, such bipolar disorder or schizophrenia as revealed by the Structured Clinical Interview for DSM-IV Disorders (100) and exclude for confounding psychiatric conditions
- Evidence of untreated depression as determined by a HAM-D Score of >12 (17-item version) or untreated anxiety by a score of > 8 on the Hamilton Anxiety Scale
- Evidence of neurologic or other physical illness that could produce cognitive deterioration.
- Volunteers with a history of TIAs, carotid bruits, or lacunae on MRI scan will be excluded
- History of myocardial infarction within the previous year or unstable cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnetic resonance imaging of hippocampal size
Time frame: Participants will complete an MRI scan which will take approximately 1 hour
Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with high resolution MRI to assess subtle MTL morphology.
Diffusion tensor imaging (DTI) to investigate white matter structure
Time frame: Participants will complete an MRI scan with DTI sequence which will take approximately 1 hour
Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with HARDI-DTI to investigate white matter structure.
Cognitive performance in a range of neuropsychological tests
Time frame: Neuropsychological testing will take approximately 3 hours
Investigators will use neuropsychological testing to assess episodic encoding and delayed memory performance. Investigators will also investigate whether any long-term cognitive deficits relate to gray matter or white matter deficits.
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 3 Nov 2020.
- Derived from this study: PubMed 30547094Burggren AC, Siddarth P, Mahmood Z, London ED, Harrison TM, Merrill DA, Small GW, Bookheimer SY. Subregional Hippocampal Thickness Abnormalities in Older Adults with a History of Heavy Cannabis Use. Cannabis Cannabinoid Res. 2018 Dec 10;3(1):242-251. doi: 10.1089/can.2018.0035. eCollection 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study Focuses on Brain Morphology and Cognition in Older Subjects, run by University of California, Los Angeles 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 12 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 3 Nov 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Magnetic resonance imaging of hippocampal size (time frame: Participants will complete an MRI scan which will take approximately 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874886, which also lists 1 linked publication.
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 3 Nov 2020.