Sublingual Nicotine Tablets Compared With Swedish Snus

NCT01838460 | Completed Phase 1

• 1 other identifier: SM WS 12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• AUCinf

  6 hours

Secondary Outcomes (4)

• craving intensity

  6 hours

• head rush

  6 hours

• burning sensation

  6 hours

• increased salivation

  6 hours

Study Arms (5)

6 mg dose of sublingual nicotine tablets

EXPERIMENTAL

6 mg dose of sublingual nicotine tablets, single dose.

Drug: sublingual nicotine tablets

PSWM 0.5 g (16 mg nicotine/g)

ACTIVE COMPARATOR

Swedish portion snus, smokeless tobacco, PSWM 0.5 g (16 mg nicotine/g), single dose

Other: Smokeless tobacco

PSWL 1.0 g (8 mg nicotine /g)

ACTIVE COMPARATOR

Swedish portion snus, smokeless tobacco, PSWL 1.0 g (8 mg nicotine /g), single dose

Other: Smokeless tobacco

PSWL 1.0 g (16 mg nicotine /g)

ACTIVE COMPARATOR

Swedish portion snus, smokeless tobacco, PSWL 1.0 g (16 mg nicotine /g), single dose

Other: Smokeless tobacco

PSWL (8 mg nicotine /g) 2x1.0 g

ACTIVE COMPARATOR

Swedish portion snus, smokeless tobacco, PSWL (8 mg nicotine /g) 2x1.0 g, single dose

Other: Smokeless tobacco

Interventions

sublingual nicotine tablets DRUG

6 mg = 3 tablets

Also known as: Nicorette Sublingual Tablets

6 mg dose of sublingual nicotine tablets

Smokeless tobacco OTHER

Swedish type moist snuff

Also known as: PSWM 0.5 g, PSWL 1.0 g

PSWL (8 mg nicotine /g) 2x1.0 g; PSWL 1.0 g (16 mg nicotine /g); PSWL 1.0 g (8 mg nicotine /g); PSWM 0.5 g (16 mg nicotine/g)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.
• Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.
• Willing and able to comply with study procedures.
• Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.
• Abstinent from any form of nicotine use from 8.00 p.m.
• Fasting overnight from 11.00 p.m.

You may not qualify if:

• Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air \>10 ppm at clinical visits"
• Second or third degree AV block or sick sinus syndrome; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of \> 450 msec for males or \> 470 msec for females); other clinically significant heart conditions which would negatively impact on the subject completing the study.
• Subjects with clinically significant liver disease which may prevent the subject from completing the study and/or an elevation in total bilirubin, alkaline phosphatase, LDH, ASAT, or ALAT of \> 3 times the upper limit of the laboratory reference interval.
• Subjects with clinically significant renal disease which may prevent the subject from completing the study and/or an elevation in serum creatinine of \> 1.5 times the laboratory reference.
• Surgery within 6 months of the Baseline visit that, in the opinion of the investigator, could negatively impact on the subject's participation in the clinical study.
• Subjects who have participated in other drug studies within 30 days prior to enrolment.
• Subjects with any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
• Subjects who are using drugs capable of inducing hepatic enzyme metabolism within the previous 30 days (or 5 half lives of inducing agent, whichever is longer) of enrolment in this study.
• Subjects with a medical history of seizures.

Sponsors & Collaborators

• Contract Research Organization el AB: lead
• Commitum AB: collaborator

Study Sites (1)

Carema Specialistvård, Eslöv

Eslöv, Skåne County, 24123, Sweden

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tobacco Products; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Erik Lunell, Md, Phd

  Croel AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: April 24, 2013
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

SE (1)