Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

Tufts University

Status: Withdrawn

Conditions: Attention Deficit Disorder; Depression; Smoking Cessation; Alcohol Drinking

Treatments: Other: Trial Withdrawn 2; Other: Trial Withdrawn 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00330434

F32AA015647-01A1 (U.S. NIH Grant/Contract)

NIAAAGRE15647

1F32AA015647-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The two purposes of this study are

1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has

   1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
   2. on the stimulant effect of bupropion and

2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has

   1. on the blood levels of bupropion and its major breakdown products in the blood and
   2. on the stimulant effect of bupropion.

Two groups of volunteers will be recruited for this study:

1. volunteers who drink moderate to heavy amounts of alcohol frequently and
2. volunteers who usually do not drink alcohol.

Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults who are 21 - 55 years of age.
• Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.

Exclusion criteria

• Participants who are currently taking prescription medications (including oral contraceptives)
• Pregnancy
• Body mass index (BMI) greater than 30
• History of seizures or eating disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Trial Withdrawn 2

Other group

Description:

Trial Withdrawn 2

Treatment:

Other: Trial Withdrawn 2

Trial Withdrawn 1

Other group

Description:

Trial Withdrawn 1

Treatment:

Other: Trial Withdrawn 1