Medication Development in Alcoholism: Investigating PPAR Agonists

• Sponsor: The Scripps Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02158273
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The primary hypotheses under test are that alcohol dependent subjects treated with fenofibrate will report decreased craving for alcohol following cue-exposure in the laboratory and report less drinking post treatment relative to placebo.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Sugar Pill; Drug: TRICOR (fenofibrate)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Medication Development in Alcoholism: Investigating PPAR Agonists
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TRICOR (fenofibrate)	Drug: TRICOR (fenofibrate); 145 mg/day, oral pill, 9 days; Other Names: Fenofibrate Fenoglide Trilipix Lipofen
Placebo Comparator: Sugar Pill	Drug: Sugar Pill; 145 mg/day, oral pill, 9 days

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period [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.

Secondary Outcome Measures

1. Change From Baseline in Standard Drinks Per Week at 1 Week [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female volunteers, 18-65 years of age

• Meets DSM-V criteria for Alcohol Use Disorder ≥ moderate severity and DSM-IV criteria for current alcohol dependence

• Subjects will not be seeking treatment because the medication studies are not treatment trials

• Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session

• Negative BAC and a CIWA score of < 9 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures

• In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests

• Females with childbearing potential must have a negative serum pregnancy test on the screening visit with a negative urine pregnancy test at randomization and agree to use an effective method of birth control for the study duration and two weeks thereafter.

• Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent

• Willingness to comply with the provisions of the protocol and take daily oral medication

Exclusion Criteria:

• Subjects with a medical condition that contraindicates the administration of fenofibrate or that will increase potential risk as determined by the Study Physician.

• GGT more than 3 times the upper limit of normal

• Female subjects with childbearing potential who are pregnant, nursing, or refuse to use an effective method of birth control for the duration of the study and two weeks thereafter

• Meets DSM-V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders (e.g., cocaine, amphetamines, heroin, PCP) other than alcohol or nicotine

• Has a positive UDS at screening or Visit 3 (laboratory session)

• Treatment within the month prior to screening with an investigational drug, vaccine or drugs that may influence study outcomes, or drugs that may pose a safety risk as determined by the Study Physician.

• History of hypersensitivity to the study drugs or the ingredients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Susan Quello	La Jolla	California	United States	92037

Sponsors and Collaborators

• The Scripps Research Institute
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Barbara J. Mason, Ph.D., The Scripps Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
• ClinicalTrials.gov Identifier: NCT02158273
• Other Study ID Numbers: AA012602-14A1; R01AA012602
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 2, 2017
• Last Verified: May 1, 2017

• Keywords provided by Barbara J. Mason, PI, The Scripps Research Institute: Alcohol; Relapse
• Additional relevant MeSH terms: Alcoholism; Fenofibrate

Study Results

Participant Flow

Arm/Group Title	Fenofibrate	Placebo
Arm/Group Description	TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Matched Placebo
Period Title: Overall Study
STARTED	25	25
COMPLETED	22	22
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Fenofibrate	Placebo	Total
Arm/Group Description	TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Matched Placebo	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.52 (12.40)	36.64 (11.84)	37.58 (12.04)
Sex: Female, Male (Count of Participants)
Female	4 16%	7 28%	11 22%
Male	21 84%	18 72%	39 78%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period
Description	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.
Time Frame	1 week following administration of fenofibrate

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fenofibrate	Placebo
Arm/Group Description	TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Matched Placebo
Measure Participants	22	22
Strength	8.94 (5.69)	10.37 (6.01)
Intent	9.83 (6.39)	11.03 (6.24)
Impulse	6.87 (6.55)	6.98 (5.62)
Relief	6.92 (6.43)	8.86 (6.00)
Total	32.56 (23.57)	37.24 (21.84)

2. Secondary Outcome

Title	Change From Baseline in Standard Drinks Per Week at 1 Week
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fenofibrate	Placebo
Arm/Group Description	TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days	Matched Placebo
Measure Participants	22	22
Drinks/week Baseline	51.21 (27.24)	47.22 (16.55)
Drinks/week Week 1	31.77 (19.53)	28.24 (11.44)
Drinks/week Change	-19.44 (19.16)	-18.98 (12.07)

Adverse Events

Arm/Group Title	Fenofibrate		Placebo
Arm/Group Description	TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days		Matched Placebo
All Cause Mortality
	Fenofibrate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fenofibrate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Fenofibrate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		2/25 (8%)
Musculoskeletal and connective tissue disorders
Myalgia	0/25 (0%)		2/25 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.