Contingency Management, Quitting Smoking, and ADHD

What Was Tested

In this phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The overall goal of the study is to evaluate how motivation and readiness for change are influenced in the context of a smoking cessation attempt.

A total of 60 adult (i.e. age 18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be enrolled into a 3-arm trial allocated as follows.

Twenty of the ADHD smokers and the 20 non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention in which monetary payments will be made contingent upon biologically verified evidence of smoking abstinence.

It had two arms (groups): Contingency Management (CM) (experimental) and Treatment as Usual (other).

The registry classes the interventions as behavioral, drug and other.

More on the Plan

Individuals with ADHD have altered reinforcement/motivational functioning that are likely related to risk for smoking and recalcitrance for quitting.

The proposed pilot research is therefore highly innovative since it will evaluate how these processes change and influence outcomes during two different kinds of smoking cessation interventions.

The project will also provide important pilot data on potential differences between ADHD and non-ADHD smokers in the context of a contingency management (CM) trial, which will help guide the development of more refined and targeted cessation interventions for this high risk group of smokers.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: 18-55 years of age. Male or female; if female of child-bearing potential, must be using an acceptable form of contraception. For ADHD Groups: confirmed primary diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview. For Control Group: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview. ADHD Symptom Ratings:.

The full record lists 11 inclusion and 5 exclusion criteria; among the exclusions: use of any psychoactive medication in the past 12 months, other than fda-approved medication for the adhd group only; estimated iq \< 80 on kaufmann brief intelligence test, second edition; has a primary diagnosis of any axis ii disorder.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-10 with completion listed for 2017-12-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire (time frame: Baseline to 9 weeks). Change in motivation to quit smoking, as measured by the Treatment Self-Regulation Questionnaire (time frame: Baseline to 9 weeks). Change in motivation to quit smoking, as measured by the Perceived Competence Scale for Cessation (time frame: Baseline to 9 weeks).

It also tracked 2 secondary outcomes, for example Change in smoking behavior in ADHD population.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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