Trial Outcomes & Findings for Medication Development in Alcoholism: Investigating PPAR Agonists (NCT NCT02158273)

Results Overview

The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

1 week following administration of fenofibrate

Results posted on

2017-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Fenofibrate TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Placebo Matched Placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medication Development in Alcoholism: Investigating PPAR Agonists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fenofibrate n=25 Participants TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Placebo n=25 Participants Matched Placebo	Total n=50 Participants Total of all reporting groups
Age, Continuous	38.52 years STANDARD_DEVIATION 12.40 • n=5 Participants	36.64 years STANDARD_DEVIATION 11.84 • n=7 Participants	37.58 years STANDARD_DEVIATION 12.04 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week following administration of fenofibrate

The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.

Outcome measures

Outcome measures
Measure	Fenofibrate n=22 Participants TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Placebo n=22 Participants Matched Placebo
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period Strength	8.94 units on a scale Standard Deviation 5.69	10.37 units on a scale Standard Deviation 6.01
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period Intent	9.83 units on a scale Standard Deviation 6.39	11.03 units on a scale Standard Deviation 6.24
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period Impulse	6.87 units on a scale Standard Deviation 6.55	6.98 units on a scale Standard Deviation 5.62
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period Relief	6.92 units on a scale Standard Deviation 6.43	8.86 units on a scale Standard Deviation 6.00
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period Total	32.56 units on a scale Standard Deviation 23.57	37.24 units on a scale Standard Deviation 21.84

SECONDARY outcome

Timeframe: 1 week

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.

Outcome measures

Outcome measures
Measure	Fenofibrate n=22 Participants TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Placebo n=22 Participants Matched Placebo
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Baseline	51.21 drinks/week Standard Deviation 27.24	47.22 drinks/week Standard Deviation 16.55
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Week 1	31.77 drinks/week Standard Deviation 19.53	28.24 drinks/week Standard Deviation 11.44
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Change	-19.44 drinks/week Standard Deviation 19.16	-18.98 drinks/week Standard Deviation 12.07

Adverse Events

Fenofibrate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fenofibrate n=25 participants at risk TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Placebo n=25 participants at risk Matched Placebo
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25	8.0% 2/25

Additional Information

Dr. Barbara Mason

The Scripps Research Institute

Phone: (858) 784-7324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place