Status:
RECRUITING
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functio...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Aged 18-65
- Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study.
- Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.
- Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of \> 5ng suggests recent use, although in some cases it has been reported that individuals may show \> 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate \> 5ng THC, the assessment may be canceled and rescheduled.
- Exclusion Criteria
- Inability to provide informed consent
- Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection
- Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications
- Seizure disorder
- Demyelinating diseases or other non-HIV neurological disorders
- Pregnancy
- Acute or recent or previous clinically disabling stroke or previous cerebrovascular events
- Lifetime history of schizophrenia or other psychotic disorders, or bipolar disorder.
- Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression) or suicidal ideas are endorsed on the BDI-II or a Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation
- Substance use disorder (mild, moderate or severe) within the last 12 months
Exclusion
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04883255
Start Date
May 3 2023
End Date
January 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
UC San Diego Medical Center-Hillcrest
San Diego, California, United States, 92103-8620