Effect of Nicotine on Brain Reward Pathways
Completed · Phase 1 · Has a placebo group
Conditions studied: Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT02346539
- Run by
- Mclean Hospital
- People needed
- 46
- Starts
- 2015-02-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-03-22
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
- Uncontrolled hypertension
- History of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone
- Heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
- Subjects that cannot speak English
Where it is running
- McLean Hospital — Belmont, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.