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Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04231643
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Perry, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE January 8, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date June 3, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
  • Score on Iowa Gambling Task [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking
  • Score on Progressive Ratio Test [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Higher scores indicate increased willingness to work for a reward
  • Scores on Probabilistic Learning Task [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Measures decision-making strategies such as win-stay, lose-shift.
  • Scores on Continuous Performance Task [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Higher scores reflect better attention and ability to discriminate important information from unimportant information
  • Percent Prepulse Inhibition (PPI) [ Time Frame: one day ]
    This is a physiological measure and not a scale with specific anchor points. Higher percent PPI reflects better sensorimotor gating
  • motor activity in the human Behavioral Pattern Monitor [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Subjects' behavior in an open field (a room filled with novel objects) is quantified over a 15-minute period via amount of motor activity as measured by a wearable accelerometer. Increased motor activity reflects increased tendency to engage in exploratory behavior.
  • object interactions in the human Behavioral Pattern Monitor [ Time Frame: one day ]
    This is an experimental measure and not a scale with specific anchor points. Subjects' behavior in an open field (a room filled with novel objects) is quantified over a 15-minute period via video ratings that quantify number of interactions with novel objects. Increased object interactions reflects increased novelty-seeking behavior.
  • cerebrospinal fluid levels of anandamide [ Time Frame: one day ]
    Reflects increased availability of the endogenous cannabinoid anandamide in the brain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers
Official Title  ICMJE A Randomized, Controlled Trial of Cannabis in Bipolar Disorder Patients and Healthy Volunteers Evaluating Cognition and Endocannabinoid Levels
Brief Summary Cannabis use is associated with younger age at onset of bipolar disorder, poor outcome, and more frequent manic episodes, but the effects of cannabis on cognition are less clear. Contrary to reports among non-psychiatric patients, cannabis may improve cognition among people with bipolar disorder. Nevertheless, no study to date has systematically tested the acute effects of cannabis on cognition in bipolar disorder. Therefore, the investigators propose to determine the effects of oral cannabinoid administration on cognitive domains relevant to bipolar disorder, e.g., arousal, decision making, cognitive control, inhibition, and temporal perception (sense of timing). In addition, the investigators will evaluate different doses of the two major components of cannabis, cannabidiol and ∆9-tetrahydrocannabinol, and compare them to placebo on these neurocognitive measures. The investigators will also test the effects of acute exposure to cannabinoids on cerebrospinal levels of anandamide and homovanillic acid - markers of endocannabinoid and dopamine activity in the brain, respectively. These studies will provide information that effectively bridges the fields of addiction and general psychiatry, informing treatment development for co-morbid substance abuse and psychiatric disorders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Dronabinol
    one-time oral administration of 5 mg dronabinol
  • Drug: Epidiolex
    one-time oral administration of 600 mg Epidiolex
  • Drug: Placebos
    one-time oral administration of placebo
Study Arms  ICMJE
  • Experimental: Bipolar Disorder
    adults with bipolar disorder
    Interventions:
    • Drug: Dronabinol
    • Drug: Epidiolex
    • Drug: Placebos
  • Active Comparator: Healthy Volunteers
    adults with no psychiatric disease
    Interventions:
    • Drug: Dronabinol
    • Drug: Epidiolex
    • Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2020)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. For subjects in BD group, DSM-5 criteria for Bipolar Disorder as determined by the Structured Clinical Interview for DSM-5 (SCID).
  2. Young Mania Rating Scale (YMRS) < 12.
  3. Infrequent cannabis use as defined by a history of cannabis use but <5 times per month [37] and no use in the past 14 days prior to experimental sessions.

Exclusion Criteria:

  1. Hamilton Depression Rating Scale (HDRS) score > 10.
  2. Suicidality. Exposure to cannabis does not lead to depression but it may be associated with suicidal thoughts and attempts. Therefore, the Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation ("I wished I were dead". "I wanted to hurt myself") will be completed. Should any of these items be answered affirmatively, e.g., the subject has endorsed these items for at least 1-2 days in the last week, the subject will not be enrolled in the study.
  3. The Substance Abuse Module of the Diagnostic Interview Schedule for DSM-5 will be administered to exclude individuals with current substance use disorders.
  4. Clinically significant or unstable medical condition. Subjects will undergo a medical evaluation (H&P, toxicology screening, and for females of childbearing potential, pregnancy testing (utilizing a human chorionic gonadotropin (hCG) urine test). Individuals with significant cardiovascular disease (e.g., angina, myocardial infarction or stroke), hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (e.g., asthma, COPD), will be excluded. With respect to cardiovascular and pulmonary status, a clinician will screen participants with a tool developed for this purpose (Appendix 3 Cardiopulmonary Screen). Hepatic and renal disease will be evaluated with liver and renal function laboratory tests. Females who are pregnant or lactating will be excluded.
  5. Infections - evidence of skin infection at lumbar puncture site.
  6. To avoid confounding of cognitive testing, a neurological disorder such as seizures, stroke, Parkinson's disease, dementia, or a history of head injury with loss of consciousness for at least 15 minutes will be excluded.
  7. Unwilling to refrain from driving or operate heavy machinery for four hours after consuming study medication. This criterion is consistent with current expert recommendations on driving following the use of cannabis.
  8. Additionally, because the hBPM paradigm requires participants to be ambulatory, those who cannot ambulate independently (e.g., require a wheelchair) or those who have a motor disease (e.g., multiple sclerosis, cerebral palsy) will be excluded.
  9. A previous adverse reaction to cannabinoids will be cause for exclusion as will a historical diagnosis of cannabis use disorder.
  10. Positive result on Draeger 5000 test indicating recent cannabis use.
  11. Unwillingness to prevent pregnancy during the cannabinoid administration portion of the study (using birth control in female participants of child-bearing age) Acceptable methods of birth control are: oral contraceptive pills, diaphragm, condom, progestin implant, intrauterine contraceptive device, sterilization, etc.
  12. Any active opportunistic infection or malignant condition requiring acute treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Participants will be asked about which gender they identify with
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nathan Wood, MA 6195436575 n2wood@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04231643
Other Study ID Numbers  ICMJE 180356
R01DA043535 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William Perry, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: William Perry, PhD UCSD
PRS Account University of California, San Diego
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP