Trial · NCT03980561

UH3 Varenicline for Cannabis Use Disorder

NCT03980561, Phase 2, Completed, Medical University of South Carolina; results first posted 2024-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. UH3 Varenicline for Cannabis Use Disorder. Trials, record NCT03980561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03980561

On this page

Trial

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

Title: UH3 Varenicline for Cannabis Use Disorder
NCT number: NCT03980561
Status: Completed
Phases: Phase 2
Enrollment: 174 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Cannabis Use Disorder
Interventions: Varenicline, Placebo
First posted: 2019-06-10
Last updated: 2024-01-18
Results first posted: 2024-01-18
Limitations and caveats: Varenicline's efficacy for cannabis use disorder may vary by sex; however, this study was not powered to fully explore potential sex differences.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Treatment phase Weeks 6-12	Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
Secondary	Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder	12 weeks (across the active treatment period)	Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.

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	Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Treatment phase Weeks 6-12	Week 6 participants	number of weekly use sessions	MEAN
SECONDARY	Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder	12 weeks (across the active treatment period)	Participants reporting an adverse event during 12 week active treatment period	number of adverse events	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Varenicline	Week 6	10.3	Standard Deviation 8.2	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Placebo	Week 6	11.6	Standard Deviation 11.4	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Varenicline	Week 7	9.4	Standard Deviation 8.2	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Placebo	Week 7	11.7	Standard Deviation 11.4	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Varenicline	Week 8	9.4	Standard Deviation 7.9	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Placebo	Week 8	10.5	Standard Deviation 11.3	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Varenicline	Week 9	8.5	Standard Deviation 7.6	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Placebo	Week 9	9.7	Standard Deviation 10.2	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Varenicline	Week 10	9.2	Standard Deviation 7.7	number of weekly use sessions
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Placebo	Week 10	10.7	Standard Deviation 10.8	number of weekly use sessions

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline	90
Overall Study	STARTED	Placebo	84
Overall Study	COMPLETED	Varenicline	61
Overall Study	COMPLETED	Placebo	59
Overall Study	NOT COMPLETED	Varenicline	29
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events28

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/depression	Psychiatric disorders	Varenicline	12	90	13
other	anxiety/depression	Psychiatric disorders	Placebo	15	84	17
other	decreased appetite	Metabolism and nutrition disorders	Varenicline	12	90	12
other	decreased appetite	Metabolism and nutrition disorders	Placebo	11	84	11
other	dream disturbance	General disorders	Varenicline	41	90	54
other	dream disturbance	General disorders	Placebo	21	84	32
other	fatigue	General disorders	Varenicline	7	90	7
other	fatigue	General disorders	Placebo	4	84	4
other	headache	General disorders	Varenicline	16	90	21
other	headache	General disorders	Placebo	25	84	28

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline	0	90
Total, all-cause mortality	Placebo	0	84
Total, other adverse events	Varenicline	81	90
Total, other adverse events	Placebo	70	84
Total, serious adverse events	Varenicline	1	90
Total, serious adverse events	Placebo	0	84

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons2

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

Comparison	Source
Varenicline vs Placebo: deaths from any cause	Trial comparisons
Varenicline 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/NCT03980561

GET https://conductscience.org/api/trials/v1/NCT03980561/results?page=2

API reference For AI assistants