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Effect of Nicotine on Brain Reward Pathways

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ClinicalTrials.gov Identifier: NCT02346539
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : December 29, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Amy C. Janes, 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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Nicotine polacrilex Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Nicotine on Brain Reward Pathways
Study Start Date : February 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nicotine

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
Single Acute dose
Other Name: Nicotine lozenge
Placebo Comparator: Placebo
Placebo comparator
Drug: Nicotine polacrilex
Single Acute dose
Other Name: Nicotine lozenge

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346539

Contact: Amy Janes, Ph.D. 617-855-3244 ajanes@mclean.harvard.edu

United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Amy C Janes, PhD    617-855-3244    ajanes@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Amy Janes, Ph.D Mclean Hospital

Responsible Party: Amy C. Janes, Assistant Professor/Neuroscientist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02346539     History of Changes
Other Study ID Numbers: 2014P002495-01
5K01DA029645-04 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amy C. Janes, Mclean Hospital:

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action