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This study examines the interactive effects of ketamine and nicotine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine and Nicotine | Active Comparator |
|
|
| Placebo Comparator | Placebo Comparator | -Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes |
|
| Ketamine and Placebo | Active Comparator | 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 |
|
| Nicotine and Placebo | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine: 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ERP recording procedures: Brain wave activity during tasks involving in processing auditory and visual stimuli with different degrees of attentional and memory demands will be recorded. | +65 | |
| IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function. | +25 | |
| Positive and Negative Syndrome Scale will be used to measure psychotic symptoms. | -90, +10, +105, +180 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Administration Hospital | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22717030 | Derived | D'Souza DC, Ahn K, Bhakta S, Elander J, Singh N, Nadim H, Jatlow P, Suckow RF, Pittman B, Ranganathan M. Nicotine fails to attenuate ketamine-induced cognitive deficits and negative and positive symptoms in humans: implications for schizophrenia. Biol Psychiatry. 2012 Nov 1;72(9):785-94. doi: 10.1016/j.biopsych.2012.05.009. Epub 2012 Jun 19. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Nicotine | Drug | 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) |
|
| Placebo | Drug | Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes |
|
| Ketamine and Nicotine | Drug | 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 nicotineIV (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) |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |