Trials Sponsors Conditions Drugs Pricing

Conditions

Smokeless Tobacco Use

Keywords

Tobacco use disorderTobacco cessation

Outcome Measures

Primary Outcomes (1)

Prolonged Smokeless Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
3 months

Secondary Outcomes (2)

Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
3 months
Prolonged Smokeless Tobacco Abstinence at 6 Months
6 months

Study Arms (2)

A

EXPERIMENTAL

4 mg nicotine lozenges for 3 months

Drug: Nicotine Lozenges

B

PLACEBO COMPARATOR

Placebo nicotine lozenges for 3 months

Drug: Placebo lozenge

Interventions

Nicotine LozengesDrug

Nicotine lozenges, 4 mg

Also known as: Commit nicotine lozenge

Placebo lozengeDrug

Placebo lozenge

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

are at least 18 years of age;
report smokeless tobacco (ST) as their primary tobacco of use;

Sponsors & Collaborators

Mayo Clinic
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Oregon Research Institute

Eugene, Oregon, 97403, United States

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title: Jon O. Ebbert, MD
Organization: Mayo Clinic

Study Officials

Jon O. Ebbert, M.D.
Mayo Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

270 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Medicine

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

January 2007

Date type not reported

This date has not been verified as actual or estimated.

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations