Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had three arms (groups): Nicotine patch - transdermal (active comparator), Placebo NRT (placebo comparator) and Healthy non-smoker comparison (no intervention).

Matching placebo patch.

Demographically-matched women and men who have never smoked.

The registry classes the interventions as drug.

More on the Plan

Women are both less likely to initiate a quit attempt and more likely to relapse if these women do quit.

The endogenous opioid system is involved in smoking initiation, nicotine craving and reward as well as nicotine withdrawal symptoms.

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.

Who Took Part

127 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 21 - 60 years old. Must meet DSM-IV criteria for nicotine dependence and be actively smoking.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-04 with completion listed for 2018-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans (time frame: 90 minutes).

It also tracked 2 secondary outcomes, for example Relationship Between Change in Mu-opioid Receptor Binding Potential and Visual Analog Craving Scale Score and Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 127 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.