Clinical trial NCT02042521: A Dietary Supplement for Early Cigarette Withdrawal
Official title: A Dietary Supplement for Early Cigarette Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence, Cigarettes, With Withdrawal
Keywords: Cigarette
Withdrawal
Nicotine
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.

Detailed description: 100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at least one week apart, in a randomized, double blind, within subject, placebo controlled design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of the night before the test day and the morning dose is taken at 8:00 of the test day) and on the other day subjects will take placebo (also taken in two doses at the same time points of the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across the two different days. Measures of mood symptom monitoring will include self report on a scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a standardized mood induction will be done with mood assessment. Symptoms of cigarette withdrawal will be assessed over the duration of withdrawal with applied standardized rating scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of a physical exam and blood work will be completed at the end of the withdrawal period on both test days as well as for the initial assessment appointment.

Eligibility criteria: Inclusion Criteria:

* males and females
* age 18-65
* generally good physical health
* not using any illicit substances
* smoke on average at least 20 cigarettes/day.

Exclusion Criteria:

* Recent history of myocardial infarction and / or stroke
* active substance abuse except for nicotine and active fluctuant medical conditions. (present and ongoing within 3 months)
* Score of higher than 7 on the 17- item Hamilton Depression Rating Scale
* Positive results for the pregnancy testing done on the first assessment visit.
* A specific allergy to fruit-based ingredient.

Primary outcomes:
measure: Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions
timeFrame: Two sessions at least one week apart
Secondary outcomes:
measure: Potential Side Effects Questionnaire
timeFrame: Twice on both test days: once in the morning right before the morning active or placebo dietary supplement and once more right after the observed break
measure: Profile of Mood States
timeFrame: Anytime during initial assessment visit. On both test days, at least 1 week apart at: (7:35-8:00); (8:40-9:05); (11:20-11:45); (12:25-12:50); (13:10-13:30); (14:30-14:55)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Research Imaging Centre, Centre for Addiction and Mental Health
name: Jeffrey H. Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: