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Puerarin Effects on Alcohol Drinking (PAD)

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Puerarin, Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • moderate to heavy alcohol drinkers (20+ drinks per week)

Exclusion Criteria:

  • alcohol dependence or treatment-seeking drinkers
  • other drug abuse or dependence
  • psychiatric disorders

Sites / Locations

  • McLean Hospital, Behavioral Psychopharmacology Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Puerarin

Placebo

Arm Description

Sugar beet filler in capsule

Outcomes

Primary Outcome Measures

Amount of Alcohol Consumed

Secondary Outcome Measures

Full Information

First Posted
February 27, 2009
Last Updated
September 1, 2011
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00854724
Brief Title
Puerarin Effects on Alcohol Drinking
Acronym
PAD
Official Title
Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.
Detailed Description
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Puerarin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar beet filler in capsule
Intervention Type
Drug
Intervention Name(s)
Puerarin, Placebo
Other Intervention Name(s)
Puerarin: NPI-031G, Placebo: Sugar beet extract
Intervention Description
400 mg, three times a day for 7 days
Primary Outcome Measure Information:
Title
Amount of Alcohol Consumed
Time Frame
During a 90 minute drinking session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: moderate to heavy alcohol drinkers (20+ drinks per week) Exclusion Criteria: alcohol dependence or treatment-seeking drinkers other drug abuse or dependence psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Penetar, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital, Behavioral Psychopharmacology Research Laboratory
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15897719
Citation
Lukas SE, Penetar D, Berko J, Vicens L, Palmer C, Mallya G, Macklin EA, Lee DY. An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy drinkers in a naturalistic setting. Alcohol Clin Exp Res. 2005 May;29(5):756-62. doi: 10.1097/01.alc.0000163499.64347.92.
Results Reference
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Puerarin Effects on Alcohol Drinking

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