NCT03206463|TerminatedPhase 1DMCFDA Drug
Study Stopped
Feasibility pilot was completed
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Feasibility pilot was completed
THC-BD
Sponsor study identifier
interventional
2
1 country
1
Study Start
August 1, 2017
Actual (reported)Primary Completion
September 29, 2017
Actual (reported)Study Completion
September 29, 2017
Actual (reported)The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness. This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2017
Actual (reported)July 2, 2017
Actual (reported)August 1, 2017
Actual (reported)September 29, 2017
Actual (reported)September 29, 2017
Actual (reported)Change in Verbal memory
Verbal memory will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
baseline and +35 mins after drug administration
Change in Executive functioning
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
baseline and +35 mins after drug administration
Attention
baseline and +35 mins after drug administration
Working memory
baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Mood
baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Psychotic-type experiences
baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Anxiety symptoms
baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Blood serum hormonal levels • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels. • Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.
baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration
Blood serum THC and metabolite levels (ng/ml)
baseline, +20 mins after drug administration, +30 mins after drug administration, +60 mins after drug administration, +90 mins after drug administration, +150 mins after drug administration, +210 mins after drug administration
Blood pressure
baseline, -60 mins before drug administration, +2, +4, +6, +8,+10, +20, +30, +35, +40, +45, +50, +60, +90, +150, +210 mins after drug administration.
Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids.
Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Mohini Ranganathan, MD
Yale University
2 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2017
First Posted
July 2, 2017
Family Workshops for Bipolar Disorder
Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids.
Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
Contact the study team to confirm eligibility.
Study Start
August 1, 2017
Actual (reported)Primary Completion
September 29, 2017
Actual (reported)Study Completion
September 29, 2017
Actual (reported)Last Updated
January 31, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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