Effect of Nicotine on Brain Reward Pathways

Depressive Disorder Clinical Trial

Official title:

Effect of Nicotine on Brain Reward Pathways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346539
• Other study ID #: 2014P002495-01
• Secondary ID: 5K01DA029645-04
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2015
• Last updated: March 21, 2018
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: March 2018
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria for subjects with Major Depressive Disorder:

1. Provide written informed consent;

2. Both genders and all ethnic origins, age between 18 and 45;

3. Meet DSM-IV diagnostic criteria for MDD (diagnosed with the use of the SCID);

4. A baseline HAM-D score of 16 or greater;

5. Absence of pregnancy;

6. Absence of any psychotropic medication for at least 2 weeks:

1. 6 weeks for fluoxetine

2. 6 months for neuroleptics

3. 2 weeks for benzodiazepines

4. 2 weeks for any other antidepressants

Inclusion Criteria for Healthy Controls

1. Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (SCID);

2. Provide written informed consent;

3. Both genders and all ethnic origins, age between 18 and 45;

4. Absence of any medications for at least 3 weeks;

5. Absence of pregnancy.

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Nicotine polacrilex
Single Acute dose

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response	Nicotine will enhance the fMRI BOLD response to monetary reinforcers relative to placebo administration	Participants will be assessed during 2 fMRI scanning sessions, an expected average of 2 weeks.