Trial · NCT01680887

A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence

NCT01680887, Phase 2, Completed, University of Pennsylvania; results first posted 2019-08-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence. Trials, record NCT01680887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01680887

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Trial

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

Title: A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence
NCT number: NCT01680887
Status: Completed
Phases: Phase 2
Enrollment: 156 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Cocaine Dependence
Interventions: Varenicline, Placebo
First posted: 2012-09-07
Last updated: 2019-08-06
Results first posted: 2019-08-06

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial	weeks 11,12,13 of the trial	Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.
Secondary	Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator	Once per week in weeks 2 through 13	As measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving.

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	Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial	weeks 11,12,13 of the trial	all subject	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator	Once per week in weeks 2 through 13		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial	Varenicline	6		Participants
Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial	Placebo	7		Participants
Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator	Varenicline	1.12	Standard Deviation 0.82	score on a scale
Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator	Placebo	0.99	Standard Deviation 0.71	score on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline	80
Overall Study	STARTED	Placebo	76
Overall Study	COMPLETED	Varenicline	51
Overall Study	COMPLETED	Placebo	52
Overall Study	NOT COMPLETED	Varenicline	29
Overall Study	NOT COMPLETED	Placebo	24

Source ClinicalTrials.gov

Adverse events48

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	aches and pains	Musculoskeletal and connective tissue disorders	Varenicline	20	80
other	aches and pains	Musculoskeletal and connective tissue disorders	Placebo	23	76
other	upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Varenicline	26	80
other	upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Placebo	27	76
other	headache	General disorders	Varenicline	15	80
other	headache	General disorders	Placebo	11	76
other	elevated blood pressure	Blood and lymphatic system disorders	Varenicline	14	80
other	elevated blood pressure	Blood and lymphatic system disorders	Placebo	11	76
other	diarrhea	Gastrointestinal disorders	Varenicline	9	80
other	diarrhea	Gastrointestinal disorders	Placebo	14	76

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline	0	80
Total, all-cause mortality	Placebo	0	76
Total, other adverse events	Varenicline	80	80
Total, other adverse events	Placebo	67	76
Total, serious adverse events	Varenicline	6	80
Total, serious adverse events	Placebo	6	76

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 comparisons3

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

Comparison	Source
Varenicline vs Placebo: Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial	Trial comparisons
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/NCT01680887

GET https://conductscience.org/api/trials/v1/NCT01680887/events?page=2

API reference For AI assistants