Trial Outcomes & Findings for Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving (NCT NCT01151813)

NCT ID: NCT01151813

Last Updated: 2020-08-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

average value over one week

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline First, Then Placebo Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.	Placebo First, Then Varenicline Placebo for one week, followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
Period 1 STARTED	8	7
Period 1 COMPLETED	8	7
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	8	7
Period 2 COMPLETED	8	7
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Within-subjects Design n=15 Participants Varenicline, oral target dose of 1.0 mg BID, one week titration; placebo, matched for one week. Double-blind counterbalanced order
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: average value over one week

Population: Comparing alcohol craving during Varenicline treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Outcome measures

Outcome measures
Measure	Varenicline First, Then Placebo n=8 Participants Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.	Placebo First, Then Varenicline n=7 Participants Placebo for one week; followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
Visual Analog Scale Alcohol Craving	20 units on a scale Interval 0.0 to 100.0	35 units on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: average value over one week

Population: Comparing cocaine craving during Varenicline treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated.

Outcome measures

Outcome measures
Measure	Varenicline First, Then Placebo n=8 Participants Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.	Placebo First, Then Varenicline n=7 Participants Placebo for one week; followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
Visual Analog Scale Cocaine Craving	25 units on a scale Interval 0.0 to 100.0	65 units on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: average over one week

Population: Comparing alcohol craving during Placebo treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving

Outcome measures

Outcome measures
Measure	Varenicline First, Then Placebo n=8 Participants Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.	Placebo First, Then Varenicline n=7 Participants Placebo for one week; followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
Visual Analog Scale Alcohol Craving 2	35 units on a scale Interval 0.0 to 100.0	55 units on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: average over one week

Population: Comparing cocaine craving during Placebo treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Outcome measures

Outcome measures
Measure	Varenicline First, Then Placebo n=8 Participants Varenicline, oral target dose of 1.0 mg BID, one week titration; followed by placebo, matched for one week.	Placebo First, Then Varenicline n=7 Participants Placebo for one week; followed by Varenicline, oral target dose of 1.0 mg BID, one week titration.
Visual Analog Scale Cocaine Craving 2	65 units on a scale Interval 0.0 to 100.0	80 units on a scale Interval 0.0 to 100.0

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Varenicline n=15 participants at risk While receiving Varenicline, oral target dose of 1.0 mg BID, one week titration	Placebo n=15 participants at risk While receiving Placebo, one week
Gastrointestinal disorders Flatulence	20.0% 3/15 • Number of events 3 • through study completion, two weeks Participants were asked to report adverse events at each study visit by nurses using a checklist of known (previously reported) adverse events, as well as novel adverse events.	6.7% 1/15 • Number of events 1 • through study completion, two weeks Participants were asked to report adverse events at each study visit by nurses using a checklist of known (previously reported) adverse events, as well as novel adverse events.

Additional Information

Dr. Jennifer Plebani

UPenn

Phone: 215-222-3200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place