Varenicline in Drug Treatment | NCT01286584

Studies
Varenicline in Drug Treatment

NCT01286584

Sponsor

Centre for Addiction and Mental Health

Status

Completed

Last Update Posted

Feb 5, 2015Estimated

Enrollment

33Actual

Phase

Phase 4

Conditions

Smoking Cessation
Alcohol Abuse

Interventions

varenicline
placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 28, 2011

First Submission Date that Met QC Criteria

Jan 28, 2011

First Posted Date

Jan 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurie Zawertailo, Independent Scientist, Centre for Addiction and Mental HealthPrincipal Investigator

Lead Sponsor

Centre for Addiction and Mental HealthOTHER

Collaborators

Name	Class
Ontario Lung Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they will be inpatients and under 24 hour medical care for the first 21 days of treatment, or receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will allow for a comprehensive assessment of the safety of varenicline in this population with minimal risk of adverse consequences. The patients will continue their cessation treatment for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH. They will also be contacted at 6 months for follow-up.

Detailed Description

Drinking alcohol and cigarette smoking are closely associated and use of one often leads to the use of the other. Also, since tobacco-related illness is the number one cause of death among recovered alcoholics it is imperative that we provide strong evidence-based treatment options for this population. Since smoking can be a strong trigger to drink in those who are dependent on both alcohol and tobacco, treating both at the same time may result in better treatment outcomes. This study will examine the efficacy of starting smoking cessation treatment while patients are in residential treatment for alcohol dependence, or outpatient in the Alcohol Research and Treatment Clinic. It will compare the effectiveness of varenicline, the most effective medication for smoking cessation with placebo. Both groups will receive weekly cessation counselling and support by a trained research analyst. We will measure abstinence from smoking at the end of the 12-week treatment period and again after 6-months to determine longer-term smoking cessation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
varenicline group	Active Comparator		Drug: varenicline
placebo group	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
varenicline	Drug	one 0.5mg varenicline capsule on first 3 days one 0.5mg varenicline capsule, twice daily for 4 days one 1.0mg varenicline capsule, twice daily until end of treatment (12weeks of medication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quit smoking rating	7-day point prevalence	end of 12-week treatment

Secondary Outcomes

Measure	Description	Time Frame
30 day continuous smoking abstinence		6-month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current daily smokers enrolled in residential treatment or outpatient in Alcohol Treatment and Research Clinic for Alcohol Use Disorder at CAMH
smoke minimum of 10 cigarettes per day
Fagerstrom Test of Nicotine Dependence score > 3
able to provide written informed consent
able and willing to attend weekly appointments at the NDC following discharge

Exclusion Criteria:

any serious medical condition requiring immediate investigation or treatment
pregnancy or lactation
current DSM-IV Axis I psychiatric disorder
any know contraindication to using varenicline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurie Zawertailo, PhD	Centre for Addiction and Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Addiction and Mental Health, Nicotine Dependence Clinic		Toronto	Ontario	M5T 1P7	Canada

References Module

Citations

Not provided

ID	Term
D016540	Smoking Cessation
D000437	Alcoholism

ID	Term
D015438	Health Behavior
D001519	Behavior
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds