N/A
Completed N=71
Study of the Effects of Mecamylamine and Varenicline in Schizophrenia
Cognition in Schizophrenia
Source: ClinicalTrials.gov NCT00455650 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability — 141.6; 120.5; 123.1; 91.2 ms
Summary
We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers.
We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia.
We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability |
141.6; 120.5; 123.1; 91.2; 83.2; 87.8 | — |
| SECONDARY Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task |
50.2; 52.8; 50.3; 54.4; 53.3; 53.5 | — |
| SECONDARY Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task |
909.2; 931.2; 894.4; 864.6; 795.8; 827.5 | — |
| SECONDARY Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task |
2.83; 2.72; 2.87; 2.29; 2.28; 2.25 | — |
Eligibility Criteria
Inclusion Criteria for Patients with Schizophrenia:
- Males or females ages 18-68
- Axis I diagnosis of schizophrenia or schizoaffective disorder
- Smoking or Non-smoking
- Negative salivary screen for drugs of abuse
- Stable psychiatric treatment for 4 weeks
Exclusion Criteria for Patients with Schizophrenia
- Current (within the last 6 months) DSM-IV diagnosis of bipolar disorder, PTSD, organic mental disorder, or anorexia nervosa
- Substance use disorder other than nicotine or caffeine in the past 6 months
- Orthostatic blood pressure changes at 3 minutes of > 20 mm Hg systolic or 10 mm Hg diastolic
- Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure 20 mm Hg systolic or 10 mm Hg diastolic
- Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure < 90 mm Hg; Men under 50 years of age: Supine baseline systolic blood pressure < 100 mm Hg; Women and men over the age of 50: Supine baseline systolic blood pressure < 110 mm Hg
- History of angina, MI within the past 2 years, CHF with LVEF < 40%
- History of syncope or neurocardiogenic syncope
- History of stroke or TIA's
- Glaucoma
- Pyloric Stenosis
- Current pregnancy or lactation
- Renal Insufficiency/Uremia
- Known allergy to mecamylamine
- Inability to give informed consent
- Cognitive impairment secondary to head injury, dementia, general medical condition, or mental retardation
- Current use of antibiotics or sulfa drugs, vasodilators such as alpha blocking agents and nitrates
- Use of investigational medication or device within one month of randomization
- Chronic use of antihypertensive drugs, including diuretics, will be considered on an individual basis
Data sourced from ClinicalTrials.gov (NCT00455650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.