Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

NCT01664741 | Completed Phase 4 Results DMC

• 2 other identifiers: NA_00036996R01DA026823
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Keywords

Nicotine dependence; cigarette; smoking; nicotine replacement therapy; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans

  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 \[1/equilibrium dissociation constant (KD)\]. We use reference tissue graphical analysis (RTGA) to obtain regional BP values using occipital lobe as a reference region. Negative BP change means means a decrease in the BP and positive BP change means an increase in the BP.

  90 minutes

Secondary Outcomes (2)

• Relationship Between Change in Mu-opioid Receptor Binding Potential and Visual Analog Craving Scale Score

  72 hours

• Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score

  72 hours

Study Arms (3)

Nicotine patch - transdermal

ACTIVE COMPARATOR

21 mg nicotine patch

Drug: Nicotine patch - transdermal

Placebo NRT

PLACEBO COMPARATOR

Matching placebo patch

Drug: placebo

Healthy non-smoker comparison

NO INTERVENTION

Demographically-matched women and men who have never smoked

Interventions

Nicotine patch - transdermal DRUG

21 mg patch

Also known as: Nicotine Replacement Therapy (NRT)

Nicotine patch - transdermal

placebo DRUG

Placebo NRT

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Drug Therapy

Results Point of Contact

• Title: Mary E McCaul
• Organization: Johns Hopkins School of Medicine

mmccaul1@jhmi.edu

410-955-9526

Study Officials

• Mary E McCaul, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)