Sublingual Nicotine Tablets Compared With Swedish Snus

Smoking Cessation Clinical Trial

Official title:

Elevated Dose of Sublingual Nicotine Tablets Compared With Swedish Snus. Nicotine Pharmacokinetics and Subjective Effects of Single Doses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838460
• Other study ID #: SM WS 12
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 19, 2013
• Last updated: April 19, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Contract Research Organization el AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old, male/female (non-pregnant), healthy volunteer, using minimum 12 pouches of 1 g portion snus or half a can of loose snus per day. The treatments are given as single doses in randomized order. The subject keeps the sublingual tablets still under the tongue for 30 minutes.

The subject keeps the pouch(es) of snus still between the upper lip and the gum for 30 minutes. Serial blood samples are drawn before, and at regular time intervals up to 6 hours after administration.

Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment. The AUCinf area is based on plasma data corrected for background nicotine (time zero sample).

Each subject's rating of subjective effects using a Visual Analogue Scale (VAS) on a palm top computer, anchored with "not at all" to "extremely".

VAS scores will be obtained at the plasma concentrations sampling time points up to 30 minutes for:

• craving intensity

• overall "product strength" (head rush, "buzz", "hit", feeling alert)

• increased salivation

• burning sensation in the mouth and/or throat

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.

2. Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.

3. Willing and able to comply with study procedures.

4. Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.

5. Abstinent from any form of nicotine use from 8.00 p.m.

6. Fasting overnight from 11.00 p.m.

Exclusion Criteria:

1. Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air >10 ppm at clinical visits"

2. 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.

3. 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.

4. 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.

5. 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.

6. Subjects who have participated in other drug studies within 30 days prior to enrolment.

7. 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.

8. 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.

9. Subjects with a medical history of seizures.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• sublingual nicotine tablets
6 mg = 3 tablets

Other:
• Smokeless tobacco
Swedish type moist snuff

Locations

Country	Name	City	State
Sweden	Carema Specialistvård, Eslöv	Eslöv	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Contract Research Organization el AB	Commitum AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf		6 hours	No
Secondary	craving intensity		6 hours	No
Secondary	head rush	overall "product strength" (head rush, "buzz", "hit", feeling alert	6 hours	No
Secondary	burning sensation	burning sensation in the mouth and/or throat	6 hours	Yes
Secondary	increased salivation		6 hours	Yes