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Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

This study is currently recruiting participants.
Verified March 2017 by Mary E. McCaul, Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664741
First Posted: August 14, 2012
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary E. McCaul, Johns Hopkins University
  Purpose
The proposed research will provide significant new gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to explain the differences in the prevalence of smoking in men and women, sex-specific differences in nicotine craving and withdrawal as well as the poorer therapeutic response to NRT. This work may pave the way to the design of improved pharmacotherapies that can more effectively target the endogenous opioid system in the treatment of nicotine dependence.

Condition Intervention Phase
Nicotine Dependence Drug: Nicotine patch - transdermal Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

Resource links provided by NLM:


Further study details as provided by Mary E. McCaul, Johns Hopkins University:

Primary Outcome Measures:
  • Mu-opioid receptor binding potential [ Time Frame: 90 minutes ]
    BP provides an estimate of the product of the density of available receptors (Bmax' or the receptor density Bmax less those occupied by endogenous transmitters) and the affinity (1/KD). Based on Zhou (2003), we use reference tissue graphical analysis (RTGA) (Schmitz, 2001) to obtain regional BP values using occipital lobe as a reference region (Schad, 2002).


Secondary Outcome Measures:
  • Nicotine craving [ Time Frame: 72 hours ]
    Tiffany Questionnaire of Smoking Urges (QSU-brief)

  • Nicotine withdrawal [ Time Frame: 72 hours ]
    Minnesota Nicotine Withdrawal Scale (MNWS)


Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine patch - transdermal
21 mg nicotine patch
Drug: Nicotine patch - transdermal
Other Name: Nicotine Replacement Therapy (NRT)
Placebo Comparator: Placebo NRT
Matching placebo patch
Drug: placebo
No Intervention: Healthy non-smoker comparison
Demographically-matched women and men who have never smoked

Detailed Description:
While smoking prevalence has declined for both men and women over the last two decades, rates among women have shown a much shallower decrease and, in recent years, prevalence of cigarette initiation has been higher for girls than boys. Smoking among women of child-bearing age has significant negative health consequences for mother and child, increasing fetal and infant morbidity and mortality. Women are both less likely to initiate a quit attempt and more likely to relapse if they do quit. Nicotine replacement therapy (NRT), still the most widely used smoking treatment intervention in the United States, is less effective for women compared with men, and women report less craving reduction on NRT. The endogenous opioid system is involved in smoking initiation, nicotine craving and reward as well as nicotine withdrawal symptoms. Interestingly, research suggests that sexual dimorphic features of the endogenous mu-opioid system may in part explain gender differences in nicotine effects. To better understand the role of the mu-opioid system in poorer NRT responses in women, this proposal will examine NRT effects on mu opioid receptor binding potential (MOR BP) in female compared to male smokers during active versus placebo NRT. Specifically, nicotine dependent women and men in active smoking status will undergo PET imaging for MOR BP measurement using 11C-carfentanil. Following baseline PET measurement in active smoking (scan 1), smokers will be randomized to active or placebo nicotine replacement therapy ((A-NRT or P-NRT); 72 hours later, a second scan will be obtained. As a reference group, demographically-matched women and men who have never smoked will undergo two scans as well. Behavioral measurements of nicotine reward, craving and withdrawal will be obtained repeatedly across the protocol. The proposed research will provide significant new, gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 - 60 years old
  • must meet DSM-IV criteria for nicotine dependence and be actively smoking

Exclusion Criteria: subjects must meet study guidelines for medical and mental health status.

  Contacts and Locations
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): NCT01664741


Contacts
Contact: JoAnna Mathena, MA 410-955-9524 jmathen5@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Mary E McCaul, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mary E McCaul, Ph.D. Johns Hopkins University
  More Information

Responsible Party: Mary E. McCaul, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01664741     History of Changes
Other Study ID Numbers: R01DA026823 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2012
First Posted: August 14, 2012
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mary E. McCaul, Johns Hopkins University:
Nicotine dependence
cigarette
smoking
nicotine replacement therapy
positron emission tomography

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
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