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A Dietary Supplement for Early Cigarette Withdrawal

NCT02042521 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-02-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Jeffrey H. Meyer, MD, PhD · Research Imaging Centre, Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042521 on ClinicalTrials.gov