NCT01438944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

September 20, 2011

Last Update Submit

April 7, 2017

Conditions

SmokingAddiction

Keywords

NRTPatchsmokingaddiction

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios

    Baseline Prior to Transdermal NRT patch application Day 4 NRT Patch Application Day 14 Last Day NRT Patch Application Day 28 14 Days post NRT patch removal.

    Baseline, Day 4, Day 14 and Day 28

Secondary Outcomes (1)

  • Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary

    Baseline, Day 14 and Day 28

Study Arms (1)

Nicabate 21mg transdermal NRT

OTHER

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

Drug: Nicabate 21mg transdermal NRT

Interventions

Nicabate 21mg transdermal NRTDRUG

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

Also known as: Nicotine replacement therapy
Nicabate 21mg transdermal NRT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristin Carson

Adelaide, South Australia, 5044, Australia

Location

MeSH Terms

Conditions

SmokingBehavior, Addictive

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

BehaviorCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Michael Roberts, BPharm PhD

    University of Queeensland, University of South Australia

    PRINCIPAL INVESTIGATOR

  • Brian Smith, MBBS, PhD

    Queen Elizabeth Hospital, University of Adelaide

    PRINCIPAL INVESTIGATOR

  • Thomas Robertson, PhD

    Therapeutics Research Centre

    PRINCIPAL INVESTIGATOR

  • Micahel Ward, PhD

    University of South Australia

    PRINCIPAL INVESTIGATOR

  • John Beltrame, MBBS, FRACP

    Queen Elizabeth Hospital, University of Adelaide

    PRINCIPAL INVESTIGATOR

  • Malcolm Brinn, BHlthSc

    Clinical Practice Unit

    PRINCIPAL INVESTIGATOR

  • Kritin Carson, PhD

    Clinical Practice Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trial co-ordinator

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 22, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

April 10, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Available upon request

Locations

AU(1)