Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction

NCT ID: NCT01438944

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-09-30

Brief Summary

Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine receptor up-regulation through an observational study using nicotine replacement therapy for two weeks and no intervention for two weeks.

Detailed Description

Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of smoking delivers nicotine through lungs into the blood stream. As a result, during smoking nicotine levels peak and then when smoking stops levels progressively diminish to a base (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine patches do not. Instead, nicotine patches deliver a constant base dose considered to be either above that of the smokers trough level or at a level where negative withdrawal effects are reduced.

The question arises as to if nicotine levels delivered by a patch are constant and potentially above that of the baseline smokers level, does this reinforce the addiction and therefore contribute to the high long term relapse rate? To answer this question the investigators will be looking at metabolites which the body uses to breakdown nicotine and several other enzymes. These metabolites respond to the levels of nicotine in the blood stream by increasing or decreasing over time. By testing blood flow, blood and urine the investigators are able to gain an insight into how the body is dealing with a constant stable dose of nicotine rather than a peak and trough dose. In combination with the questionnaires the investigators will be able to determine the level of affect.

Conditions

Smoking; Addiction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nicabate 21mg transdermal NRT

21mg Transdermal NRT applied for 24hrs over a 14day period.

Group Type: OTHER

Nicabate 21mg transdermal NRT

Intervention Type: DRUG

Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.

Interventions

Nicabate 21mg transdermal NRT

Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.

Intervention Type: DRUG

Other Intervention Names

Nicotine replacement therapy

Eligibility Criteria

Inclusion Criteria

• Smokers who currently smoke at least 10 cigarettes per day
• Aged between 18 and 75
• Informed consent
• Willingness to attempt to quit smoking for the period specified, initially with a transdermal patch for 14 days and then without any smoking cessation aids for a further 14 days.

Exclusion Criteria

• Use of bupropion, champix or nicotine containing products other than cigarettes in the last 2 months
• previous reactions to NRT
• Pregnancy / Breast Feeding
• Uncontrolled hypertension
• Unstable angina
• Heart attack or stroke within the previous 6 months
• Severe Obesity as indicated by Body Mass Index (BMI) ≥35 (potential for slow release of nicotine from tissues)
• acute psychiatric illness, past history psychosis, suicidal ideation or current diminished capacity.
• Current treatment or recent diagnosis of cancer
• Current use of Phenobarbital or other anticonvulsant drugs (induction of metabolism of nicotine to cotinine)
• Renal failure (creatinine clearance<30ml/min - reduces metabolic clearance of cotinine and nicotine)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Basil Hetzel Institute for Translational Research

UNKNOWN

Sponsor Role: collaborator

University of Adelaide

OTHER

Sponsor Role: collaborator

University of South Australia

OTHER

Sponsor Role: collaborator

Clinical Practice Unit

UNKNOWN

Sponsor Role: collaborator

Therapeutics Research Centre

UNKNOWN

Sponsor Role: collaborator

The Queen Elizabeth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristin Carson

Trial co-ordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Roberts, BPharm PhD

Role: PRINCIPAL_INVESTIGATOR

University of Queeensland, University of South Australia

Brian Smith, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, University of Adelaide

Thomas Robertson, PhD

Role: PRINCIPAL_INVESTIGATOR

Therapeutics Research Centre

Micahel Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Australia

John Beltrame, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, University of Adelaide

Malcolm Brinn, BHlthSc

Role: PRINCIPAL_INVESTIGATOR

Clinical Practice Unit

Kritin Carson, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Practice Unit

Locations

Kristin Carson

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

2011039

Identifier Type: -

Identifier Source: org_study_id