CYP2B6 Polymorphisms in Ketamine

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-05-31

Brief Summary

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This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ketamine arm- 1/1

1.\*1/\*1- oral racemic ketamine 0.4 mg/kg

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

0.4 mg/kg oral racemic ketamine

Ketamine arm - 1/6

2\. \*1/\*6- oral racemic ketamine 0.4 mg/kg

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

0.4 mg/kg oral racemic ketamine

Ketamine arm - 6/6

3\. \*6/\*6- oral racemic ketamine 0.4 mg/kg

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

0.4 mg/kg oral racemic ketamine

Interventions

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ketamine

0.4 mg/kg oral racemic ketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 18-50 yr old
2. CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G\>T, 785A\>G, 983T\>C or 1459C\>T polymorphism may be enrolled at PI's discretion)
3. Good general health with no remarkable medical conditions
4. BMI \<33
5. Provided informed consent

Exclusion Criteria

1. Known history of liver or kidney disease
2. Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
3. Females who are pregnant or nursing
4. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes