Trial Outcomes & Findings for A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence (NCT NCT01680887)

Last Updated: 2019-08-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

156 participants

Primary outcome timeframe

weeks 11,12,13 of the trial

Results posted on

2019-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline Oral 1.0 mg BID. Varenicline	Placebo Oral 1.0 mg BID. Placebo
Overall Study STARTED	80	76
Overall Study COMPLETED	51	52
Overall Study NOT COMPLETED	29	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=80 Participants Oral 1.0 mg BID. Varenicline	Placebo n=76 Participants Oral 1.0 mg BID. Placebo	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	75 Participants n=7 Participants	155 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	60 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants	68 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	76 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: weeks 11,12,13 of the trial

Population: all subject

Outcome measures

Outcome measures
Measure	Varenicline n=80 Participants Oral 1.0 mg BID. Varenicline	Placebo n=76 Participants Oral 1.0 mg BID. 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	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Varenicline n=80 Participants Oral 1.0 mg BID. Varenicline	Placebo n=76 Participants Oral 1.0 mg BID. Placebo
Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator	1.12 score on a scale Standard Deviation 0.82	0.99 score on a scale Standard Deviation 0.71

Adverse Events

Varenicline

Serious events: 6 serious events

Other events: 80 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Varenicline n=80 participants at risk varenicline 2 mg daily	Placebo n=76 participants at risk Identical placebo capsules
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders Lower abdominal mass	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.
Psychiatric disorders Cocaine use disorder exacerbation	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.
Psychiatric disorders Substance induced depression	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders gastroenteritis	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Vascular disorders orthostatic hypotension	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Cardiac disorders chest pain, cocaine induced	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.
Psychiatric disorders oiate detoxification	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.
Cardiac disorders mitral valve replacement	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Cardiac disorders chest pain	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.
General disorders gunshot wound	0.00% 0/80 • 17 weeks Adverse events were queried at each visit.	1.3% 1/76 • Number of events 1 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders nausea	1.2% 1/80 • Number of events 1 • 17 weeks Adverse events were queried at each visit.	0.00% 0/76 • 17 weeks Adverse events were queried at each visit.

Other adverse events

Other adverse events
Measure	Varenicline n=80 participants at risk varenicline 2 mg daily	Placebo n=76 participants at risk Identical placebo capsules
Musculoskeletal and connective tissue disorders aches and pains	25.0% 20/80 • 17 weeks Adverse events were queried at each visit.	30.3% 23/76 • 17 weeks Adverse events were queried at each visit.
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	32.5% 26/80 • 17 weeks Adverse events were queried at each visit.	35.5% 27/76 • 17 weeks Adverse events were queried at each visit.
General disorders headache	18.8% 15/80 • 17 weeks Adverse events were queried at each visit.	14.5% 11/76 • 17 weeks Adverse events were queried at each visit.
Blood and lymphatic system disorders elevated blood pressure	17.5% 14/80 • 17 weeks Adverse events were queried at each visit.	14.5% 11/76 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders diarrhea	11.2% 9/80 • 17 weeks Adverse events were queried at each visit.	18.4% 14/76 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders abdominal pain	13.8% 11/80 • 17 weeks Adverse events were queried at each visit.	11.8% 9/76 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders nausea	23.8% 19/80 • 17 weeks Adverse events were queried at each visit.	6.6% 5/76 • 17 weeks Adverse events were queried at each visit.
General disorders toothache	10.0% 8/80 • 17 weeks Adverse events were queried at each visit.	9.2% 7/76 • 17 weeks Adverse events were queried at each visit.
Nervous system disorders vivid dreams	13.8% 11/80 • 17 weeks Adverse events were queried at each visit.	2.6% 2/76 • 17 weeks Adverse events were queried at each visit.
General disorders fatigue	6.2% 5/80 • 17 weeks Adverse events were queried at each visit.	9.2% 7/76 • 17 weeks Adverse events were queried at each visit.
Gastrointestinal disorders flatulence	7.5% 6/80 • 17 weeks Adverse events were queried at each visit.	6.6% 5/76 • 17 weeks Adverse events were queried at each visit.
General disorders lightheadedness	5.0% 4/80 • 17 weeks Adverse events were queried at each visit.	7.9% 6/76 • 17 weeks Adverse events were queried at each visit.

Additional Information

Kyle Kampman

Perelman School of Medicine

Phone: 215 746 2764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place