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N/A N=82 Treatment

Neural Basis of Eating Behavior in Abstinent Smokers

Nicotine Use Disorder

Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Abstinence Induced Change in Task BOLD Signal Change — 0.000; -0.014; 0.027; 0.051 percentage of signal change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Practice Quit Attempt (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Abstinence Induced Change in Task BOLD Signal Change
0.000; -0.014; 0.027; 0.051; -0.011; 0.055

Summary

The purpose of this research study is to better understand why people gain weight when they quit smoking by examining food intake and changes in brain activity in smokers when they are smoking as usual compared to when they have been deprived of cigarettes (i.e., have not smoked for 4 days) as compared to a non-smoker control group.

Eligibility Criteria

Inclusion Criteria

Male and female participants who are between 18 and 45 years of age.

Smoking group - 80 treatment-seeking smokers who self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. Smoking status will be confirmed by CO greater than or equal to 8 parts per million (ppm) at the Intake Visit.

Non-smoking group - 30 individuals reporting fewer than 100 lifetime cigarettes and not even a puff of a cigarette for a minimum of 2 years. Smoking status of non-smokers will be confirmed by CO less than 5ppm. They will be matched to the smoker group on age, sex, and education.

Plan to live in the area for the duration of the study (i.e. ~8 weeks/2 months).

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 1-2 months greater than 50.

Able to communicate fluently in English (i.e. speaking, writing, and reading).

Exclusion Criteria

Subjects who present and/or self-report with the following criteria will not be eligible to participate in the study:

Smoking Behavior

  • Regular use of nicotine-containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine- containing products other than cigarettes will be considered eligible.
  • Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. ~8 weeks/2 months).
  • Anticipated use (within the next ~8 weeks/2 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study.
  • Provide a CO breath test reading less than 8 ppm at Intake Visit (smokers) or greater than 5ppm at intake visit (non-smokers).

Alcohol and Drug

  • History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
  • Current alcohol consumption that exceeds 25 standard drinks/week.
  • Breath alcohol reading (BrAC) greater than .000 at the Intake Visit.
  • A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit.

Medical

  • Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration of the study.
  • Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months.
  • Poorly controlled, brittle, or pump-dependent Type I diabetes.
  • Current peptic ulcer bleeding.
  • Active hepatitis or poorly controlled kidney and/or liver disease.
  • Serious or unstable disease within the past 6 months. Notable diseases will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
  • Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
  • Applicable food allergies or disorders:
  • Galactosemia a
  • Notable milk allergy (lactose intolerant participant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03438188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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