Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

The overall rationale for this revised study design remains similar to the original.

It had two arms (groups): Vyvanse and transdermal nicotine patch (experimental) and Placebo and transdermal nicotine patch (placebo comparator).

The second group will receive matching placebo and NRT after the quit date.

The registry classes the interventions as drug.

More on the Plan

This will be a 2-group, parallel, placebo-controlled, double blind study.

Participants will attend a total of 16 visits over a period of 7-11 weeks.

The primary outcome measure for this study will be the proportion of individuals in each group who report 4 weeks continuous smoking abstinence verified by both Carbon Monoxide (CO) levels and salivary cotinine, measured at Visit 5.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Attention Deficit Hyperactivity Disorder(ADHD) diagnosis. Smokes at least \> 10 cigarettes per day. No major medical problems. No contraindications to treatment with either LDX or transdermal nicotine.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: other psychiatric conditions that require medication; body mass index (bmi) \> 35.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

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

It started in 2007-12 with completion listed for 2011-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels <= 4 Ppm for Each Post-quit Study Visit (time frame: 4 weeks).

It also tracked 6 secondary outcomes, for example Smoking Rates, Continuous Performance Test (CPT) Commission Errors, Continuous Performance Test (CPT) Reaction Time Standard Error, ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms and N-back Test Proportion Correct Across 4 Load Factors.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 32 people.

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

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.