Phase 4 N=25 Randomized Triple-blind Treatment

Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01664741 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans — -2.47; -5.94; 5.60; -1.24 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nicotine patch - transdermal (Drug); placebo (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans	-2.47; -5.94; 5.60; -1.24; -9.25; 0.59	—
SECONDARY Relationship Between Change in Mu-opioid Receptor Binding Potential and Visual Analog Craving Scale Score	0.556; -0.550	—
SECONDARY Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score	-0.087; -0.836; 0.419; -0.794	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01664741). 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.