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Effects of Varenicline on Smoking Reminders (VSMK)

Primary Purpose

Nicotine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Varenicline

Placebo

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smokers, fMRI, varenicline

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence or psychiatric diagnosis.
Smoke ≥ 10 cigarettes per day for at least 6 months prior to study start date.
Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control from at least 2 weeks prior to screening until 30 days after the last dose of varenicline. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
Subjects provide voluntary informed consent.
Subjects must read at 8th grade level or higher.

Exclusion Criteria:

History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
Presence of magnetically active prosthetics, plates, pins, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
Self report of HIV positive and on medication for symptoms: Determined on an individual basis by results from the physical examination and final approval by the study physician.
Symptomatic presence of other hematological disease.
Clinically significant hepatic (liver), renal (kidney), neurological, or endocrinological abnormalities.
History of any cardiovascular event within the last 6 months and any serious/significant cardiovascular event in the subject's life. This will be determined on an individual basis by the study physician.
History of psychosis or seizures.
Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated on a case-by-case basis).
Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.

Sites / Locations

University of Pennsylvania Addiction Treatment Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

Varenicline

Arm Description

Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Outcomes

Primary Outcome Measures

Cigarettes Per Day

Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled

Secondary Outcome Measures

Full Information

NCT ID

NCT01524627

First Posted

January 10, 2012

Last Updated

August 15, 2017

Sponsor

University of Pennsylvania

Collaborators

National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01524627

Brief Title

Effects of Varenicline on Smoking Reminders

Acronym

VSMK

Official Title

Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Varenicline is the best smoking cessation agent to date; however it is only effective in a subgroup of smokers and is associated with undesirable side effects in other subgroups. To understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion functional magnetic resonance imaging and a functional candidate gene association approach using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic varenicline administration in smokers. Brain and behavioral responses to smoking cues will be will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats. For the purposes of the clinical trial portion of the study, the change from cigarettes per day at Baseline to the last day of treatment will be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

Smokers, fMRI, varenicline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Arm Title

Varenicline

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Chantix

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

Primary Outcome Measure Information:

Title

Cigarettes Per Day

Description

Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled

Time Frame

last week of treatment (1-8 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence or psychiatric diagnosis. Smoke ≥ 10 cigarettes per day for at least 6 months prior to study start date. Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control from at least 2 weeks prior to screening until 30 days after the last dose of varenicline. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence. Subjects provide voluntary informed consent. Subjects must read at 8th grade level or higher. Exclusion Criteria: History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. Presence of magnetically active prosthetics, plates, pins, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body. Self report of HIV positive and on medication for symptoms: Determined on an individual basis by results from the physical examination and final approval by the study physician. Symptomatic presence of other hematological disease. Clinically significant hepatic (liver), renal (kidney), neurological, or endocrinological abnormalities. History of any cardiovascular event within the last 6 months and any serious/significant cardiovascular event in the subject's life. This will be determined on an individual basis by the study physician. History of psychosis or seizures. Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated on a case-by-case basis). Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresa Franklin, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania Addiction Treatment Research Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Effects of Varenicline on Smoking Reminders

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