Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects

Yale University

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Nicotine; Drug: Placebo; Drug: Ketamine; Drug: Ketamine and Nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT00690170

18014

Details and patient eligibility

About

This study examines the interactive effects of ketamine and nicotine.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 18-50 years old
• Smokers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 4 patient groups, including a placebo group

Ketamine and Nicotine

Active Comparator group

Description:

* 0.23 mg/kg of ketamine bolus IV (in the arm) over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes. * 13.5 µg/kg of nicotine IV (in the arm) given over 10 min (1.35 µg/min/kg), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg)

Treatment:

Drug: Ketamine and Nicotine

Placebo Comparator

Placebo Comparator group

Description:

-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes

Treatment:

Drug: Placebo

Ketamine and Placebo

Active Comparator group

Description:

Ketamine administration: 0.23 mg/kg bolus over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes Placebo administration: Normal saline (sodium chloride 0.9%)over 94 minutes

Treatment:

Drug: Ketamine

Nicotine and Placebo

Active Comparator group

Description:

Nicotine: 13.5 µg/kg given over 10 min (1.35 µg/min/kg)IV (in the arm), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg) Placebo: Normal saline (sodium chloride 0.9%)IV (in the arm)

Treatment:

Drug: Nicotine