A Dietary Supplement for Early Cigarette Withdrawal

NCT ID: NCT02042521

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Nicotine Dependence, Cigarettes, With Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Healthy Smokers (Active then Placebo)

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: DRUG

The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.

Lactose Placebo

Intervention Type: DRUG

This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.

Healthy Smokers (Placebo then Active)

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: DRUG

The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.

Lactose Placebo

Intervention Type: DRUG

This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.

Interventions

Dietary Supplement

The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.

Intervention Type: DRUG

Lactose Placebo

This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.

Intervention Type: DRUG

Other Intervention Names

Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Jeff Meyer

Program Head, Neurochemical Imaging for Mood Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey H. Meyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Imaging Centre, Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.camh.ca/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

021 / 2013

Identifier Type: -

Identifier Source: org_study_id