A Dietary Supplement for Early Cigarette Withdrawal (CIGAR)

Center for Addiction and Mental Health (CAMH)

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence, Cigarettes, With Withdrawal

Treatments: Drug: Dietary Supplement; Drug: Lactose Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02042521

021 / 2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

21 participants in 2 patient groups

Healthy Smokers (Active then Placebo)

Experimental group

Description:

Healthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo

Treatment:

Drug: Lactose Placebo

Drug: Dietary Supplement

Healthy Smokers (Placebo then Active)

Experimental group

Description:

Healthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo

Treatment:

Drug: Lactose Placebo

Drug: Dietary Supplement