Trial · NCT03242928

Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

NCT03242928, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD). Trials, record NCT03242928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03242928

On this page

Trial

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

Title: Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
NCT number: NCT03242928
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Cocaine-related Disorder
Interventions: AFQ056, Placebo
First posted: 2017-08-08
Last updated: 2021-10-08
Other registries' IDs: eudract:2017-000736-33
Results first posted: 2021-02-04

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Proportion of Cocaine Use Days	Day 1 up to day 98	The cocaine consumption was recorded once daily (Yes/No) by the subject using the Timeline Follow-Back (TLFB) cocaine assessment tool during the treatment period. For each patient, the proportion of cocaine use days was calculated by dividing the number of days of cocaine use during the treatment period, i.e. 98 days for completers and number of days between Day 1 and day of last dose in case of premature discontinuation of study treatment.
Secondary	Proportion of Positive Urine Measurements of Benzoylecgonine (BE)	Day 1 up to day 98	Urine samples were analyzed for the presence of cocaine's metabolite benzoylecgonine (BE) which is the main metabolite of cocaine present in urine. Two urine samples were provided per week to provide a quantitative measure.
Secondary	Proportion of Days of Alcohol Consumption	Day 1 up to day 98	Alcohol consumption was recorded by the subjects using the Timeline Follow-Back (TLFB) alcohol self report. The number of standard drinks were recorded daily. The proportion of days of alcohol consumption during the study treatment period was was compared using an ANCOVA model with treatment as factor and past alcohol consumption as covariate. The past consumption of alcohol was the proportion of alcohol over the 28 days preceding the screening visit, which was assessed retrospectively using the TLFB.
Secondary	AFQ056 Plasma Concentrations	Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)	Plasma samples were collected to assess pharmacokinetics (PK)

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Cocaine Use Days	Day 1 up to day 98	Pharmacodynamic analysis set (PD): subjects with any available efficacy (PD) data, who received study drug for at least 14 days with no relevant protocol deviation	cocaine use days	MEAN
SECONDARY	Proportion of Positive Urine Measurements of Benzoylecgonine (BE)	Day 1 up to day 98		positive urine samples	MEAN
SECONDARY	Proportion of Days of Alcohol Consumption	Day 1 up to day 98	Pharmacodynamic analysis set (PD): subjects with any available efficacy (PD) data, who received study drug for at least 14 days with no relevant protocol deviation	alcohol consumption days	MEAN
SECONDARY	AFQ056 Plasma Concentrations	Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)	Number of samples available for analysis varied across time points	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Proportion of Cocaine Use Days	AFQ056		0.122	Standard Error 0.027	cocaine use days
Proportion of Cocaine Use Days	Placebo		0.209	Standard Error 0.024	cocaine use days
Proportion of Positive Urine Measurements of Benzoylecgonine (BE)	AFQ056		0.666	Standard Error 0.057	positive urine samples
Proportion of Positive Urine Measurements of Benzoylecgonine (BE)	Placebo		0.843	Standard Error 0.051	positive urine samples
Proportion of Days of Alcohol Consumption	AFQ056		0.233	Standard Error 0.030	alcohol consumption days
Proportion of Days of Alcohol Consumption	Placebo		0.303	Standard Error 0.026	alcohol consumption days
AFQ056 Plasma Concentrations	AFQ056	Day 15 0 hour	41.2	Standard Deviation 47.4	ng/mL
AFQ056 Plasma Concentrations	AFQ056	Day 15 2 hour	78.0	Standard Deviation 91.7	ng/mL
AFQ056 Plasma Concentrations	AFQ056	Day 29 0 hour	83.5	Standard Deviation 116	ng/mL
AFQ056 Plasma Concentrations	AFQ056	Day 29 2 hour	148	Standard Deviation 131	ng/mL

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AFQ056	31
Overall Study	STARTED	Placebo	37
Overall Study	COMPLETED	AFQ056	22
Overall Study	COMPLETED	Placebo	32
Overall Study	NOT COMPLETED	AFQ056	9
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events232

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	Iron deficiency anaemia	Blood and lymphatic system disorders	AFQ056	1	31	1
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Placebo	0	37	0
other	Monocytosis	Blood and lymphatic system disorders	AFQ056	0	31	0
other	Monocytosis	Blood and lymphatic system disorders	Placebo	1	37	1
other	Tachycardia	Cardiac disorders	AFQ056	0	31	0
other	Tachycardia	Cardiac disorders	Placebo	1	37	1
other	Ear pain	Ear and labyrinth disorders	AFQ056	1	31	1
other	Ear pain	Ear and labyrinth disorders	Placebo	0	37	0
other	Tinnitus	Ear and labyrinth disorders	AFQ056	1	31	1
other	Tinnitus	Ear and labyrinth disorders	Placebo	0	37	0

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AFQ056	0	31
Total, all-cause mortality	Placebo	0	37
Total, other adverse events	AFQ056	26	31
Total, other adverse events	Placebo	30	37
Total, serious adverse events	AFQ056	0	31
Total, serious adverse events	Placebo	1	37

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
AFQ056 vs Placebo: deaths from any cause	Trial comparisons
AFQ056 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/NCT03242928

GET https://conductscience.org/api/trials/v1/NCT03242928/events?page=2

API reference For AI assistants