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

Smoking Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428310
• Other study ID #: RCP-006
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2011
• Last updated: October 29, 2015
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2015
• Source: Rock Creek Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Smoking
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Dietary Supplement:
• Anatabloc(TM)
one dissolvable bit, one time, after a period of abstinence from smoking
• CigRx(R)
one dissolvable bit, one time, after a period of abstinence from smoking

Locations

Country	Name	City	State
United States	Comfort Inn	Martinsburg	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Rock Creek Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on subject's craving to smoke	craving is assessed by changes in questionnaire answers over time	5 hours	No
Secondary	adverse events related to study product	collection of information on adverse events related to study product	5 hours	No