Trial · NCT04596267

Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers

NCT04596267, Phase 1, Terminated, Boston Medical Center; results first posted 2023-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers. Trials, record NCT04596267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04596267

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
NCT number: NCT04596267
Status: Terminated
Phases: Phase 1
Enrollment: 9 participants, actual
Lead sponsor: Boston Medical Center
Conditions: Alcohol Use Disorder, Alcohol Drinking
Interventions: Pitolisant, Placebo
First posted: 2020-10-22
Last updated: 2023-12-04
Results first posted: 2023-12-04
Limitations and caveats: Recruitment was impacted by COVID-19 restrictions on human subject research, leading to a smaller number of subjects analyzed than planned. This study start date was also delayed due to problems securing the medication supply.

Source ClinicalTrials.gov

Registered outcomes39

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Alcohol Consumption in Alcohol Self-Administration Trials	2.6 hours	Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.
Primary	Alcohol Consumption (BAC): Observation Period, Minute 10	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable
Primary	Alcohol Consumption (BAC): Observation Period, Minute 20	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Observation Period, Minute 30	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Observation Period, Minute 40	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Self-administration Block 1, Minute 30	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Self-administration Block 1, Minute 60	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Self-administration Block 2, Minute 30	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Primary	Alcohol Consumption (BAC): Self-administration Block 2, Minute 60	1 minute	Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Secondary	Alcohol Craving During 12-day Drug Exposure	12 days	The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication exposure period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. Higher VAS scores are associated with more cravings. Lower VAS scores are favorable.

1 to 10 of 39Source ClinicalTrials.gov

See all 39 registered outcomes

Outcomes39

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Alcohol Consumption in Alcohol Self-Administration Trials	2.6 hours	A total of 9 subjects were randomized and 7 completed.	Total SDUs	MEAN
PRIMARY	Alcohol Consumption (BAC): Observation Period, Minute 10	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Observation Period, Minute 20	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Observation Period, Minute 30	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Observation Period, Minute 40	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Self-administration Block 1, Minute 30	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Self-administration Block 1, Minute 60	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Self-administration Block 2, Minute 30	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
PRIMARY	Alcohol Consumption (BAC): Self-administration Block 2, Minute 60	1 minute	A total of 9 subjects were randomized and 7 completed.	Grams of alcohol/210 Liters of breath	MEAN
SECONDARY	Alcohol Craving During 12-day Drug Exposure	12 days	A total of 9 subjects were randomized and 7 completed.	score on a scale	MEAN

1 to 10 of 39Source ClinicalTrials.gov

See all 39 outcomes

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Alcohol Consumption in Alcohol Self-Administration Trials	Pitolisant	67.214	Standard Deviation 25.759	Total SDUs
Alcohol Consumption in Alcohol Self-Administration Trials	Placebo	66.786	Standard Deviation 15.369	Total SDUs
Alcohol Consumption (BAC): Observation Period, Minute 10	Pitolisant	0.034	Standard Deviation 0.005	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 10	Placebo	0.033	Standard Deviation 0.010	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 20	Pitolisant	0.038	Standard Deviation 0.009	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 20	Placebo	0.0364	Standard Deviation 0.011	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 30	Pitolisant	0.037	Standard Deviation 0.003	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 30	Placebo	0.034	Standard Deviation 0.009	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 40	Pitolisant	0.033	Standard Deviation 0.006	Grams of alcohol/210 Liters of breath
Alcohol Consumption (BAC): Observation Period, Minute 40	Placebo	0.031	Standard Deviation 0.006	Grams of alcohol/210 Liters of breath

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Medication Dispense/Exposure Period 1	STARTED	Pitolisant Then Placebo	4
Medication Dispense/Exposure Period 1	STARTED	Placebo Then Pitolisant	5
Medication Dispense/Exposure Period 1	COMPLETED	Pitolisant Then Placebo	3
Medication Dispense/Exposure Period 1	COMPLETED	Placebo Then Pitolisant	4
Medication Dispense/Exposure Period 1	NOT COMPLETED	Pitolisant Then Placebo	1
Medication Dispense/Exposure Period 1	NOT COMPLETED	Placebo Then Pitolisant	1
Alcohol Self-Administration Trial 1	STARTED	Pitolisant Then Placebo	3
Alcohol Self-Administration Trial 1	STARTED	Placebo Then Pitolisant	4
Alcohol Self-Administration Trial 1	COMPLETED	Pitolisant Then Placebo	3
Alcohol Self-Administration Trial 1	COMPLETED	Placebo Then Pitolisant	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events10

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	Bright yellow urine	Renal and urinary disorders	Pitolisant	2	7	2
other	Bright yellow urine	Renal and urinary disorders	Placebo	2	7	2
other	Nausea	Gastrointestinal disorders	Pitolisant	1	7	1
other	Nausea	Gastrointestinal disorders	Placebo	0	7	0
other	Increased Thirst	General disorders	Pitolisant	1	7	1
other	Increased Thirst	General disorders	Placebo	0	7	0
other	Left Ankle Pain	General disorders	Pitolisant	1	7	1
other	Left Ankle Pain	General disorders	Placebo	0	7	0
other	Right knee contusion with abrasion	General disorders	Pitolisant	1	7	1
other	Right knee contusion with abrasion	General disorders	Placebo	0	7	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pitolisant	0	7
Total, all-cause mortality	Placebo	0	7
Total, other adverse events	Pitolisant	2	7
Total, other adverse events	Placebo	2	7
Total, serious adverse events	Pitolisant	0	7
Total, serious adverse events	Placebo	0	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
R21AA028864	The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers	DEVINE, ERIC G.	BOSTON MEDICAL CENTER	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2020 to 2021

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pitolisant vs Placebo: deaths from any cause	Trial comparisons
Pitolisant vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04596267

GET https://conductscience.org/api/trials/v1/NCT04596267/registered?page=2

API reference For AI assistants