Effect of Nicotine on Brain Reward Pathways
Overview
- Phase
- Phase 1
- Intervention
- Nicotine polacrilex
- Conditions
- Depressive Disorder
- Sponsor
- Mclean Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The investigators will determine whether an acute dose of nicotine, in the form of the nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in individuals with major depressive disorder.
Investigators
Amy C. Janes
Assistant Professor/Neuroscientist
Mclean Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects with suicidal ideation where outpatient treatment is determined unsafe. These patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment;
- •Serious or unstable medical illness
- •Lifetime history of seizure disorder;
- •Lifetime history or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, ADHD, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD;
- •Patients with a lifetime history of electroconvulsive therapy (ECT);
- •Failure to meet standard MRI safety requirements;
- •May not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
- •Must have an expired carbon monoxide level of less than or equal to 10 ppm.
- •Use of anticholinergic drugs in the past week
- •Any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
Arms & Interventions
Nicotine
2mg of nicotine in the form of a nicotine polacrilex lozenge will be administered orally, one time. 4mg of nicotine in the form of a nicotine polacrilex lozenge will be administered orally, one time.
Intervention: Nicotine polacrilex
Placebo
Placebo comparator
Intervention: Nicotine polacrilex
Outcomes
Primary Outcomes
Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response
Time Frame: Participants will be assessed during 2 fMRI scanning sessions, an expected average of 2 weeks.
Nicotine will enhance the fMRI BOLD response to monetary reinforcers relative to placebo administration