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

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.

Conditions

• Smoking
• Addiction

Interventions

DRUG

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.

Sponsors & Collaborators

• Basil Hetzel Institute for Translational Research

  collaborator UNKNOWN

• University of Adelaide

  collaborator OTHER

• University of South Australia

  collaborator OTHER

• Clinical Practice Unit

  collaborator UNKNOWN

• Therapeutics Research Centre

  collaborator UNKNOWN

• The Queen Elizabeth Hospital

  lead OTHER

Principal Investigators

• Michael Roberts, BPharm PhD · University of Queeensland, University of South Australia

• Brian Smith, MBBS, PhD · Queen Elizabeth Hospital, University of Adelaide

• Thomas Robertson, PhD · Therapeutics Research Centre

• Micahel Ward, PhD · University of South Australia

• John Beltrame, MBBS, FRACP · Queen Elizabeth Hospital, University of Adelaide

• Malcolm Brinn, BHlthSc · Clinical Practice Unit

• Kritin Carson, PhD · Clinical Practice Unit

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2015-07-31

Completion

2015-09-30

Countries

• Australia

Study Locations