NCT01262170

Brief Summary

A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

December 15, 2010

Last Update Submit

October 29, 2015

Conditions

SmokingTobacco Use Disorder

Keywords

dietary supplementnutraceutical

Outcome Measures

Primary Outcomes (1)

  • Effect on subject's craving to smoke

    craving is assessed by changes in questionnaire answers over time

    4 hours

Secondary Outcomes (1)

  • Collection of information on adverse events related to study products

    5 hours

Study Arms (2)

CigRx Lozenge

EXPERIMENTAL

CigRx Lozenge

Dietary Supplement: CigRx Lozenge

Tobacco Lozenge

ACTIVE COMPARATOR

Tobacco Lozenge

Other: Tobacco Lozenge

Interventions

CigRx LozengeDIETARY_SUPPLEMENT

lozenge made of dietary supplements

CigRx Lozenge
Tobacco LozengeOTHER

lozenge made of compressed cured tobacco extract

Tobacco Lozenge

Eligibility Criteria

Age23 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult smokers
  • Smoking for at least 5 years
  • Smoking at least one (1) pack of cigarettes a day

You may not qualify if:

  • Allergy to lozenge components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comfort Inn

Martinsburg, West Virginia, 25401, United States

Location

MeSH Terms

Conditions

SmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Maria Varga, MD

    Star Scientific, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 17, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

US(1)