A Dietary Supplement for Early Cigarette Withdrawal

NCT02042521 | Completed Phase 2

• 1 other identifier: 021 / 2013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence, Cigarettes, With Withdrawal

Keywords

Cigarette; Withdrawal; Nicotine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Potential Side Effects Questionnaire

  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

  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)

Study Arms (2)

Healthy Smokers (Active then Placebo)

EXPERIMENTAL

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

Drug: Dietary Supplement; Drug: Lactose Placebo

Healthy Smokers (Placebo then Active)

EXPERIMENTAL

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

Drug: Dietary Supplement; Drug: Lactose Placebo

Interventions

Dietary Supplement 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.

Healthy Smokers (Active then Placebo); Healthy Smokers (Placebo then Active)

Lactose Placebo 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.

Also known as: Placebo

Healthy Smokers (Active then Placebo); Healthy Smokers (Placebo then Active)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

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

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jeffrey H. Meyer, MD, PhD

  Research Imaging Centre, Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Head, Neurochemical Imaging for Mood Disorders

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

CA (1)