Effect of Nicotine on Brain Reward Pathways

NCT02346539 | Completed Phase 1

• 2 other identifiers: 2014P002495-015K01DA029645-04
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

Nicotine; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Nicotine

EXPERIMENTAL

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.

Drug: Nicotine polacrilex

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Nicotine polacrilex

Interventions

Nicotine polacrilex DRUG

Single Acute dose

Also known as: Nicotine lozenge

Nicotine; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent;
• Both genders and all ethnic origins, age between 18 and 45;
• Meet DSM-IV diagnostic criteria for MDD (diagnosed with the use of the SCID);
• A baseline HAM-D score of 16 or greater;
• Absence of pregnancy;
• Absence of any psychotropic medication for at least 2 weeks:
• weeks for fluoxetine
• months for neuroleptics
• weeks for benzodiazepines
• weeks for any other antidepressants
• Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (SCID);
• Provide written informed consent;
• Both genders and all ethnic origins, age between 18 and 45;
• Absence of any medications for at least 3 weeks;
• Absence of pregnancy.

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

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• Wang KS, Brown K, Frederick BB, Moran LV, Olson D, Pizzagalli DA, Kaiser RH, Janes AC. Nicotine acutely alters temporal properties of resting brain states. Drug Alcohol Depend. 2021 Sep 1;226:108846. doi: 10.1016/j.drugalcdep.2021.108846. Epub 2021 Jun 24.

  PMID: 34198131 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Amy Janes, Ph.D

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Neuroscientist

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)