Trial · NCT03655717
Using Imaging to Assess Effects of THC on Brain Activity
NCT03655717, Not applicable, Completed, Massachusetts General Hospital; results first posted 2022-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Using Imaging to Assess Effects of THC on Brain Activity. Trials, record NCT03655717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03655717
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Using Imaging to Assess Effects of THC on Brain Activity
- NCT number
- NCT03655717
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 316 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Intoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC
- Interventions
- Dronabinol, Ethanol, Placebo dronabinol, Placebo ethanol
- First posted
- 2018-08-31
- Last updated
- 2022-07-28
- Results first posted
- 2022-07-28
- Limitations and caveats
After reviewing and updating the study record to appropriately reflect the approved protocol, it was determined that the entry for Study Phase is best represented as N/A, rather than Phase 4, as the purpose of the study is NOT to investigate the safety or efficacy of the drug. This study seeks to use dronabinol only to probe and describe brain physiology. The change from Phase 4 to N/A more accurately and reflects the IRB approved protocol, and the aims of the grant that funds the research.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration. | Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). |
| Other | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State. | The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration. | Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration. | Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies).~Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects) | Δ mol/L | MEAN |
| OTHER_PRE_SPECIFIED | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State. | The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration. | Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies).~Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects) | Δ mol/L | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2A: Dronabinol Only | Predose | 0.00000000042 | Standard Deviation 0.00000011109 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2A: Placebo Dronabinol Only | Predose | -0.00000000126 | Standard Deviation 0.00000012928 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Dronabinol and Ethanol | Predose | -0.00000000271 | Standard Deviation 0.00000015932 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Dronabinol and Placebo Ethanol | Predose | -0.00000000114 | Standard Deviation 0.00000015048 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Placebo Dronabinol and Ethanol | Predose | -0.00000000151 | Standard Deviation 0.00000009318 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Placebo Dronabinol and Placebo Ethanol | Predose | -0.00000000219 | Standard Deviation 0.00000012507 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2A: Dronabinol Only | Peak | 0.00000000013 | Standard Deviation 0.00000010190 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2A: Placebo Dronabinol Only | Peak | 0.00000000029 | Standard Deviation 0.00000012394 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Dronabinol and Ethanol | Peak | -0.00000000041 | Standard Deviation 0.00000010552 | Δ mol/L |
| Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Phase 2B: Dronabinol and Placebo Ethanol | Peak | -0.00000000020 | Standard Deviation 0.00000012457 | Δ mol/L |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 2A: AB | 70 | |
| Overall Study | STARTED | Phase 2A: BA | 68 | |
| Overall Study | STARTED | Phase 2B: CDEF | 2 | |
| Overall Study | STARTED | Phase 2B: CDFE | 1 | |
| Overall Study | STARTED | Phase 2B: CEDF | 0 | |
| Overall Study | STARTED | Phase 2B: CEFD | 3 | |
| Overall Study | STARTED | Phase 2B: CFDE | 3 | |
| Overall Study | STARTED | Phase 2B: CFED | 3 | |
| Overall Study | STARTED | Phase 2B: DCEF | 2 | |
| Overall Study | STARTED | Phase 2B: DCFE | 1 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anxiety | Psychiatric disorders | Phase 2A: Dronabinol Only | 5 | 128 | 5 |
| other | Anxiety | Psychiatric disorders | Phase 2A: Placebo Dronabinol Only | 2 | 126 | 2 |
| other | Anxiety | Psychiatric disorders | Phase 2B: Dronabinol and Ethanol | 3 | 39 | 3 |
| other | Anxiety | Psychiatric disorders | Phase 2B: Dronabinol and Placebo Ethanol | 4 | 39 | 4 |
| other | Anxiety | Psychiatric disorders | Phase 2B: Placebo Dronabinol and Ethanol | 0 | 32 | 0 |
| other | Anxiety | Psychiatric disorders | Phase 2B: Placebo Dronabinol and Placebo Ethanol | 0 | 38 | 0 |
| other | Cold | Infections and infestations | Phase 2A: Dronabinol Only | 5 | 128 | 5 |
| other | Cold | Infections and infestations | Phase 2A: Placebo Dronabinol Only | 2 | 126 | 2 |
| other | Cold | Infections and infestations | Phase 2B: Dronabinol and Ethanol | 2 | 39 | 2 |
| other | Cold | Infections and infestations | Phase 2B: Dronabinol and Placebo Ethanol | 1 | 39 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2A: Dronabinol Only | 0 | 128 |
| Total, all-cause mortality | Phase 2A: Placebo Dronabinol Only | 0 | 126 |
| Total, all-cause mortality | Phase 2B: Dronabinol and Ethanol | 0 | 39 |
| Total, all-cause mortality | Phase 2B: Dronabinol and Placebo Ethanol | 0 | 39 |
| Total, all-cause mortality | Phase 2B: Placebo Dronabinol and Ethanol | 0 | 32 |
| Total, all-cause mortality | Phase 2B: Placebo Dronabinol and Placebo Ethanol | 0 | 38 |
| Total, other adverse events | Phase 2A: Dronabinol Only | 13 | 128 |
| Total, other adverse events | Phase 2A: Placebo Dronabinol Only | 6 | 126 |
| Total, other adverse events | Phase 2B: Dronabinol and Ethanol | 7 | 39 |
| Total, other adverse events | Phase 2B: Dronabinol and Placebo Ethanol | 12 | 39 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R42DA043977 | Advancing a novel portable detection method for cannabis intoxication | EVINS, A EDEN | HIGHLIGHTI, INC | NATIONAL INSTITUTE ON DRUG ABUSE | 2017 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
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 |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary 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.
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