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OpenTrials
Completed

NCT Number: NCT02346539

Effect of Nicotine on Brain Reward Pathways

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for subjects with Major Depressive Disorder:

  • 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:
  • 6 weeks for fluoxetine
  • 6 months for neuroleptics
  • 2 weeks for benzodiazepines
  • 2 weeks for any other antidepressants

Inclusion criteria

for Healthy Controls

  • 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.

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
  • 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

Treatment and study plan

Nicotine polacrilex

Drug

Single Acute dose

Other names: Nicotine lozenge

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2015
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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