A Dietary Supplement for Early Cigarette Withdrawal (CIGAR)

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence, Cigarettes, With Withdrawal
• Intervention / Treatment: Drug: Dietary Supplement; Drug: Lactose Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Smokers (Active then Placebo); Healthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo	Drug: 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.; 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.; Other Names: Placebo
Experimental: Healthy Smokers (Placebo then Active); Healthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo	Drug: 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.; 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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions	VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compared to the change score on the day with the placebo dietary supplement.	Two sessions at least one week apart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential Side Effects Questionnaire	Structured questionnaires to assess the potential occurrence of side effects from Component A and Component B of the DS. In general, reported Component A side effects are fairly minor. Some of the reported side effects include nausea, headaches, fatigue, heartburn and joint pain. Reported side effects with Component B include: drowsiness, nausea and headaches, dizziness, fatigue, and lethargy	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
Profile of Mood States	The POMS contains 65 adjectives rated by participants on a 5-point scale. Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion.	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)

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Jeffrey H. Meyer, MD, PhD, Research Imaging Centre, Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Nicotine; Cigarette; Withdrawal
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 021 / 2013