Trial · NCT04249882

A Novel Human Lab Model for Screening AUD Medications

NCT04249882, Phase 2, Completed, University of California, Los Angeles; results first posted 2023-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Novel Human Lab Model for Screening AUD Medications. Trials, record NCT04249882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04249882

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Trial

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

Title: A Novel Human Lab Model for Screening AUD Medications
NCT number: NCT04249882
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: University of California, Los Angeles
Conditions: Alcohol Use Disorder
Interventions: Placebo, Naltrexone, Varenicline
First posted: 2020-01-31
Last updated: 2023-09-14
Results first posted: 2023-09-14

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percentage of Days Abstinent	6 days	The percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period.
Primary	# of Drinks Per Drinking Day	6 days	The drinks per drinking day outcome is determined using the the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the number of drinks per drinking day during the practice quit period.
Primary	Cue-induced Craving	Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure	Randomized participants completed a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first does of study medication, and again on Day 14. After every 3 minutes of exposure (water and alcohol), participants rated their urge to drink on the Alcohol Urge Questionnaire (AUQ). The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving, with higher total scores indicating higher craving and a minimum score of 8 and maximum score of 56. Alcohol urge questionnaire score (alcohol minus water) is the primary outcome for the cue-reactivity paradigm. The investigators are primarily interested in the difference in craving from post-treatment (day 14) to pre-treatment (randomization/day 1).

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percentage of Days Abstinent	6 days	percent days	LEAST_SQUARES_MEAN
PRIMARY	# of Drinks Per Drinking Day	6 days	number of drinks per drinking day	LEAST_SQUARES_MEAN
PRIMARY	Cue-induced Craving	Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Percentage of Days Abstinent	Placebo	80.59	Standard Error 6.67	percent days
Percentage of Days Abstinent	Varenicline	75.62	Standard Error 6.87	percent days
Percentage of Days Abstinent	Naltrexone	77.59	Standard Error 7.31	percent days
# of Drinks Per Drinking Day	Placebo	1.66	Standard Error 0.63	number of drinks per drinking day
# of Drinks Per Drinking Day	Varenicline	2.19	Standard Error 0.65	number of drinks per drinking day
# of Drinks Per Drinking Day	Naltrexone	2.73	Standard Error 0.69	number of drinks per drinking day
Cue-induced Craving	Placebo	-0.11	Standard Error 0.35	units on a scale
Cue-induced Craving	Varenicline	0.31	Standard Error 0.33	units on a scale
Cue-induced Craving	Naltrexone	-0.32	Standard Error 0.37	units on a scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	19
Overall Study	STARTED	Varenicline	19
Overall Study	STARTED	Naltrexone	15
Overall Study	COMPLETED	Placebo	17
Overall Study	COMPLETED	Varenicline	17
Overall Study	COMPLETED	Naltrexone	14
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Varenicline	2
Overall Study	NOT COMPLETED	Naltrexone	1

Source ClinicalTrials.gov

Adverse events72

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
other	Abdominal Pain or Cramps	Gastrointestinal disorders	Placebo	3	19
other	Abdominal Pain or Cramps	Gastrointestinal disorders	Varenicline	4	19
other	Abdominal Pain or Cramps	Gastrointestinal disorders	Naltrexone	4	15
other	Yellow Eyes	Eye disorders	Placebo	2	19
other	Yellow Eyes	Eye disorders	Varenicline	1	19
other	Yellow Eyes	Eye disorders	Naltrexone	1	15
other	Nausea or Vomiting	Gastrointestinal disorders	Placebo	1	19
other	Nausea or Vomiting	Gastrointestinal disorders	Varenicline	5	19
other	Nausea or Vomiting	Gastrointestinal disorders	Naltrexone	3	15
other	Irritability or Anger	Psychiatric disorders	Placebo	5	19

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	19
Total, all-cause mortality	Varenicline	0	19
Total, all-cause mortality	Naltrexone	0	15
Total, other adverse events	Placebo	15	19
Total, other adverse events	Varenicline	13	19
Total, other adverse events	Naltrexone	14	15
Total, serious adverse events	Placebo	0	19
Total, serious adverse events	Varenicline	0	19
Total, serious adverse events	Naltrexone	0	15

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33225963	DERIVED	PubMed
40080609	DERIVED	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
R21AA027180	A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder	RAY, LARA A.	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2019 to 2021

Source NIH RePORTER

Trial comparisons0

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

None in this release.

Tests1

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
Food Cue Reactivity Task	Primary outcome

Source ConductCognition

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/NCT04249882

GET https://conductscience.org/api/trials/v1/NCT04249882/events?page=2

API reference For AI assistants