Effect of Nicotine on Brain Reward Pathways

NCT ID: NCT02346539

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine polacrilex

Intervention Type: DRUG

Single Acute dose

Placebo

Placebo comparator

Group Type: PLACEBO_COMPARATOR

Nicotine polacrilex

Intervention Type: DRUG

Single Acute dose

Interventions

Nicotine polacrilex

Single Acute dose

Intervention Type: DRUG

Other Intervention Names

Nicotine lozenge

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amy C. Janes

Assistant Professor/Neuroscientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Janes, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34198131 (View on PubMed)

Other Identifiers

5K01DA029645-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014P002495-01

Identifier Type: -

Identifier Source: org_study_id