Trial · NCT03717272
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjective Effects of Cannabis | On Days 1, 2, 3, 4 and 5 of each Period: Mean VAS will be assessed predose and postdose | Mean Visual Analog Scale (VAS) rating assessing positive subjective drug effect, (Good Drug Effect). This scale uses a 0-100mm rating, where higher numbers indicate a better drug effect. |
| Secondary | Changes in cannabis self-administration | On Days 2, 3, 4 and 5 of each Period: at 5.5 hours, 7.5 hours , 9.5 hours and 11.5 hours post dose | Number of purchased puffs of cannabis cigarette per day (possibility of 0-24 puffs per day). Higher numbers indicate more cannabis self-administration. |
| Secondary | Percent Change in Subjective Ratings of Cannabis. | On Days 1, 2, 3, 4 and 5 of each Period: CRF will be completed at 3.84 hours, 4.17 hours , 4.5 hours, 5.0 hours and 5.25 hours postdose | Five-item Cannabis Rating Form Visual Analog Scale (CRF-VAS) where subjects report, on a 0-100mm scale, ratings of 'cannabis strength', 'liking', 'desire to take again', 'good cannabis effect', and 'bad cannabis effect'. Higher reported ratings indicate more agreement with each term. |
| Secondary | Changes in pain threshold and pain tolerance | Baseline at 1430 hours; experimenter-administered cannabis at 1445 hours; CPT at 1515 hours, 1545 hours, 1615 hours, 1645 hours and 1745 hours | Changes in pain response (threshold and tolerance) as a function of cannabis and medication condition will be assessed using the Cold pressor test. Pain threshold is determined by latency (in seconds) to first self-report of subjective feelings of pain while the hand is immersed in cold water (4 degrees celsius), and pain tolerance is determined by latency (in seconds) to hand withdrawal from cold water. |
| Secondary | Cognitive Performance (Sustained Attention) | On Days 1, 2, 3, 4 and 5 of each Period, at 0.5 hours and 4.5 hours post dose | Sustained Attention to Response Task (SART). Participants are presented with a single digit 1-9 in the middle of the screen in varying font sizes. The digit disappears after a short while and is replaced with a mask (circle with an X). Participants are asked to press the spacebar if any digit other than 3 is presented and to withhold the response if digit 3 presented. The outcome is the total number of correct suppressions. More correct suppressions indicate better cognitive performance. |
| Secondary | Cognitive Performance (Processing speed) | On Days 1, 2, 3, 4 and 5 of each Period, at 0.5 hours and 4.5 hours post dose | Digit Symbol Substitution Task (DSST). Participants are presented with an 18 (columns) x 16 (rows) matrix. Odd rows contain symbols, even rows contain empty answer boxes (18x8 = 144). The task is to translate the symbols into digits with the help of a provided key within a 2 min time frame. The outcome is the total number of correct responses. More correct responses indicate better cognitive performance. |
| Secondary | Cognitive Performance (Recognition Memory) | On Days 1, 2, 3, 4 and 5 of each Period, at 0.5 hours and 4.5 hours post dose | Behavioral Pattern Separation Task. The first part of the experiment presents 128 pictures (default) of everyday items and participants have to decide whether the item is an OUTDOOR or an INDOOR item. The second part of the experiment presents 64 of the previously seen pictures (targets), 64 of very similar items (lures), and 64 new items (foils). Participants are asked to categorize the items as old, new, or similar within 2.5s (default) The outcome is percent correct. Higher percentage correct indicates better cognitive performance. |
| Secondary | Cognitive Performance (Reaction time) | On Days 1, 2, 3, 4 and 5 of each Period, at 0.5 hours and 4.5 hours post dose | Color Stroop Task. Participants are given names of color words written in varying color ink, and are asked to indicate the printed color of the word (not its meaning) by pressing a key as fast as they can without making too many errors. The outcome is mean reaction time of correctly answered trials. More correctly answered trials indicates better cognitive performance. |
| Secondary | AUC (area under curve) of AEF0117 Plasma exposure | Pharmacokinetic measures (e.g., 0, 3 hours, 9.5 hours and 24hours post first dose and 24 hours after the last dose administered on Day5 | Plasmatic exposure to AEF0117 |
| Secondary | AUC of Plasma concentrations of THC | Pharmacokinetic measures (e.g., 0, 3 hours, 9.5 hours and 24 hours post first dose and 24 hours after the last dose administered on Day5 | Plasmatic exposure to THC |
| Secondary | AUC of Plasma concentrations of 11-OH-THC | Pharmacokinetic measures (e.g., 0, 3 hours, 9.5 hours and 24hours post first dose and 24 hours after the last dose administered on Day5 | Plasmatic exposure to 11-OH-THC |
| Secondary | AUC of Plasma concentrations of 11-COOH-THC | Pharmacokinetic measures (e.g., 0, 3 hours, 9.5 hours and 24 hours post first dose and 24 hours after the last dose administered on Day5 | Plasmatic exposure to 11-COOH-THC |
| Secondary | Food intake | Daily from Day 1 to Day 5 of each period | Daily caloric intake will be calculated by recording and summing the calorie counts for all food items each participant consumes on each day. Consumption of food items will be self-reported by each participant, and verified by checking each participant's trash every day during the inpatient phase. |
| Secondary | Sleep Quality | Each day during inpatient phase at -0.75h prior to medication dosing. | Self-reported 7-item Visual Analog Scale (VAS) of sleep quality. Participants rate, on a 0-100mm scale, the following: 'I slept well last night', 'I woke up early this morning', 'I fell asleep easily last night', 'I feel clear-headed this morning', 'I woke up often last night', 'I am satisfied with my sleep last night', and 'I had a lot of dreams last night'. Higher ratings indicate more agreement with each statement. |
| Secondary | Sleep Quantity | Daily from Day 1 to Day 5 of each period | Number of hours slept as measured by an Actiwatch worn by the participant each night. Higher numbers indicate more hours slept. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [safety and tolerability] | Screening, Predose on Day 1 and on Day 6 | Collection of AE, weight, hematology, serum chemistry and urinalysis |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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