Effect of Nicotine on Brain Reward Pathways

Phase 1

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Nicotine polacrilex

• Registration Number: NCT02346539
• Lead Sponsor: Mclean Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Study Start: 2015-02
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

1. 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;
2. Serious or unstable medical illness
3. Lifetime history of seizure disorder;
4. 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;
5. Patients with a lifetime history of electroconvulsive therapy (ECT);
6. Failure to meet standard MRI safety requirements;
7. May not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
8. Must have an expired carbon monoxide level of less than or equal to 10 ppm.
9. Use of anticholinergic drugs in the past week
10. Any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
11. Uncontrolled hypertension
12. 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
13. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
14. Subjects that cannot speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine	Nicotine polacrilex	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.
Placebo	Nicotine polacrilex	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response	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

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States