Trial Outcomes & Findings for HBPL Study of the Impact of the NK1 Antagonist Aprepitant (NCT NCT01176591)

Results Overview

The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Session 1

Results posted on

2020-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Session 1, Aprepitant Session 2 Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo in Session 1, Placebo in Session 2 Placebo, one per session, oral administration
Session 1 STARTED	10	3
Session 1 COMPLETED	10	3
Session 1 NOT COMPLETED	0	0
Session 2 STARTED	10	3
Session 2 COMPLETED	10	3
Session 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HBPL Study of the Impact of the NK1 Antagonist Aprepitant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session1, Placebo Session 2 n=3 Participants Placebo, one per session, oral administration	Total n=13 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex/Gender, Customized Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	3 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Session 1

Population: Comparing Placebo to Placebo

The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 1	19 units on a scale Interval 0.0 to 95.0	48 units on a scale Interval 1.0 to 100.0

PRIMARY outcome

Timeframe: Session 1

Population: Comparing Placebo to Placebo

The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Alcohol Craving as Measured by the Visual Analog Scale (VAS) 1	26.25 units on a scale Interval 0.0 to 94.0	38.92 units on a scale Interval 2.0 to 100.0

PRIMARY outcome

Timeframe: Session 2

Population: Comparing Aprepitant to Placebo

The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 2	20 units on a scale Interval 0.0 to 84.0	4 units on a scale Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: Session 2

Population: Comparing Aprepitant to Placebo

The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Alcohol Craving as Measured by the Visual Analog Scale (VAS) 2	33.22 units on a scale Interval 0.0 to 84.0	0.17 units on a scale Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Session 1

Population: Comparing Placebo to Placebo

The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values. The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine. MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Multiple Choice Procedure (MCP) 1	8.58 dollars Interval 0.75 to 20.0	17.33 dollars Interval 12.0 to 20.0

SECONDARY outcome

Timeframe: Session 2

Population: Comparing Aprepitant to Placebo

The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values. The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine. MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.

Outcome measures

Outcome measures
Measure	Placebo Session 1, Aprepitant Session 2 n=10 Participants Placebo in session 1; Aprepitant: 80 mg in session 2, oral administration.	Placebo Session 1, Placebo Session 2 n=3 Participants Placebo in Session 1, Placebo in Session 2, oral administration
Multiple Choice Procedure (MCP) 2	7.59 dollars Interval 0.75 to 16.0	17.33 dollars Interval 12.0 to 20.0

Adverse Events

Placebo Session1, Aprepitant Session 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Session1, Placebo Session 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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