Trial Outcomes & Findings for Effect of LY686017 on Alcohol Craving (NCT NCT00310427)

NCT ID: NCT00310427

Last Updated: 2010-04-20

Results Overview

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2010-04-20

Participant Flow

66 subjects were initially screened for the study by undergoing a baseline alcohol cue reactivity test. Eight subjects were assessed as non-reactive and excluded from the study. In addition, 2 subjects refused to participate, and 3 subjects were excluded for other reasons. Thus, 53 subjects were randomized to the two treatment arms.

Participant milestones

Measure	LY686017 Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo Subjects received placebo orally on a daily basis.
Overall Study STARTED	27	26
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of LY686017 on Alcohol Craving

Baseline characteristics by cohort

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Craving for Alcohol (Spontaneous)	19.7 Units on a scale Standard Error 2.3	19.1 Units on a scale Standard Error 2.4

PRIMARY outcome

Timeframe: Week 1/Rating 1 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the First of Two Weekly Ratings.	-4.59 Units on a scale Standard Error 1.70	-1.52 Units on a scale Standard Error 2.92

PRIMARY outcome

Timeframe: Week 1 Rating 2 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the Second of Two Weekly Ratings.	-5.72 Units on a scale Standard Error 2.13	-4.14 Units on a scale Standard Error 2.30

PRIMARY outcome

Timeframe: Week 2 Rating 1 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the First of Two Weekly Ratings.	-6.40 Units on a scale Standard Error 2.10	-2.43 Units on a scale Standard Error 2.69

PRIMARY outcome

Timeframe: Week 2 Rating 2 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the Second of Two Weekly Ratings.	-6.88 Units on a scale Standard Error 2.10	-4.32 Units on a scale Standard Error 2.52

PRIMARY outcome

Timeframe: Week 3 Rating 1 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the First of Two Weekly Ratings.	-7.84 Units on a scale Standard Error 1.88	-3.33 Units on a scale Standard Error 3.24

PRIMARY outcome

Timeframe: Week 3 Rating 2 minus baseline

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the Second of Two Weekly Ratings.	-9.24 Units on a scale Standard Error 2.14	-7.44 Units on a scale Standard Error 2.58

PRIMARY outcome

Timeframe: Week 4

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	LY686017 n=25 Participants Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 Participants Subjects received placebo orally on a daily basis.
Craving for Alcohol Evoked by Alcohol-cue Challenge	19.2 Units on a scale Standard Error 2.18	23.2 Units on a scale Standard Error 2.62

Adverse Events

LY686017

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LY686017 n=25 participants at risk Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis	Placebo n=25 participants at risk Subjects received placebo orally on a daily basis.
Gastrointestinal disorders Abdominal cramps	4.0% 1/25	8.0% 2/25
Metabolism and nutrition disorders Decreased appetite	8.0% 2/25	0.00% 0/25
Gastrointestinal disorders Diarrhea	12.0% 3/25	8.0% 2/25
General disorders Dizziness	12.0% 3/25	8.0% 2/25
General disorders Fatigue	44.0% 11/25	20.0% 5/25
Gastrointestinal disorders Flatulence	4.0% 1/25	8.0% 2/25
General disorders Headache	24.0% 6/25	24.0% 6/25
Gastrointestinal disorders Nausea	12.0% 3/25	8.0% 2/25
Skin and subcutaneous tissue disorders Rash or pruritus	8.0% 2/25	4.0% 1/25
General disorders Xerostomia	8.0% 2/25	4.0% 1/25

Additional Information

Markus A. Heilig, M.D., Ph.D.

NIH/National Institute on Alcohol Abuse and Alcoholism

Phone: 301-435-9386

Email: mheilig@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place