Skip to main content
OpenTrials
Completed

NCT Number: NCT01428310

Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke

This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Dependence

Age range

23 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comfort Inn

Martinsburg, West Virginia, 25404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult smokers
  • using at least 1 pack of cigarettes per day, for at least 5 years

Exclusion criteria

  • allergy to study product components

Treatment and study plan

Anatabloc(TM)

Dietary Supplement

one dissolvable bit, one time, after a period of abstinence from smoking

CigRx(R)

Dietary Supplement

one dissolvable bit, one time, after a period of abstinence from smoking

Primary outcomes

  1. effect on subject's craving to smoke

    Time frame: 5 hours

    craving is assessed by changes in questionnaire answers over time

Secondary outcomes

  1. adverse events related to study product

    Time frame: 5 hours

    collection of information on adverse events related to study product

Sponsors and collaborators

Lead sponsor

Rock Creek Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 2, 2011
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.