Puerarin Effects on Alcohol Drinking

NCT ID: NCT00854724

Last Updated: 2011-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Puerarin

Group Type ACTIVE_COMPARATOR

Puerarin, Placebo

Intervention Type DRUG

400 mg, three times a day for 7 days

Placebo

Sugar beet filler in capsule

Group Type PLACEBO_COMPARATOR

Puerarin, Placebo

Intervention Type DRUG

400 mg, three times a day for 7 days

Interventions

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Puerarin, Placebo

400 mg, three times a day for 7 days

Intervention Type DRUG

Other Intervention Names

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Puerarin: NPI-031G Placebo: Sugar beet extract

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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David M. Penetar

Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David M. Penetar, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital, Behavioral Psychopharmacology Research Laboratory

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15897719 (View on PubMed)

Other Identifiers

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R44AA152200

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P-000726

Identifier Type: -

Identifier Source: org_study_id

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