Phase 4
Completed N=25
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
Source: ClinicalTrials.gov NCT01664741 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans — -2.47; -5.94; 5.60; -1.24 ratio
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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.
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. Informational only — not medical advice.