Trial · NCT03717272
Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects
NCT03717272, Phase 2, Completed, Aelis Farma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects. Trials, record NCT03717272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03717272
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects
- NCT number
- NCT03717272
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Aelis Farma
- Conditions
- Marijuana Abuse
- Interventions
- AEF0117, Placebo oral capsule
- First posted
- 2018-10-24
- Last updated
- 2021-06-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37291212 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA038875 | Non-Metabolized Pregnenolone Derivatives:New Treatment for Cannabis Use Disorder | HANEY, MARGARET | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON DRUG ABUSE | 2016 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Mnemonic Similarity Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Sustained Attention to Response | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03717272
GET https://conductscience.org/api/trials/v1/NCT03717272/registered