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Baclofen Effects in Cigarette Smokers (BAC)

Primary Purpose

Nicotine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Baclofen

placebo

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine Addiction, fMRI, Baclofen

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Physically healthy, as determined by a comprehensive physical examination and approval of the study physician males or females who smoke cigarettes, ages 18-60.
Smoke ≥ 6 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. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), the Nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection or complete abstinence.
Provide voluntary informed consent.
Must be able to read. [Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.]
Intelligence quotient of ≥ 80.

Exclusion Criteria:

History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
Current Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnoses other than nicotine dependence.
Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (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.
History of psychosis.
Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.
Current diagnosis of or treatment within the last 3 months for alcohol dependence.
Current use of any smoking cessation treatments such as Zyban, Chantix, Wellbutrin, patch, gum, inhaler, electronic cigarettes, herbal preparations.
Vision problems that cannot be corrected with glasses.
Weight exceeding 300 pounds [Imaging data acquisition is impaired with high weight individuals].
History of stroke.

Sites / Locations

University of Pennsylvania Center for Studies of Addiction

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar pill

Baclofen

Arm Description

Placebo-treated subjects will follow the identical schedule as Baclofen subjects.

Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.

Outcomes

Primary Outcome Measures

Cigarettes Smoked Per Day

Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group

Secondary Outcome Measures

Full Information

NCT ID

NCT01821560

First Posted

March 21, 2013

Last Updated

November 30, 2018

Sponsor

University of Pennsylvania

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01821560

Brief Title

Baclofen Effects in Cigarette Smokers

Acronym

BAC

Official Title

Baclofen Effects on Brain and Behavior in Cigarette Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (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

The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive smoking reminders (cues that motivate continued smoking and relapse). These studies will provide a means to identify an appetitive cue-sensitive pharmacologic-responsive endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to treatment, smoking cessation treatments can be structured to meet individual needs, which will significantly improve treatment outcome.

6. Conditions and Keywords

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

Nicotine Dependence

Keywords

Nicotine Addiction, fMRI, Baclofen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

Placebo-treated subjects will follow the identical schedule as Baclofen subjects.

Arm Title

Baclofen

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Baclofen

Other Intervention Name(s)

Kemstro, Lioresal, Liofen, Gablofen, Beklo

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Cigarettes Smoked Per Day

Description

Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group

Time Frame

3 weeks (Scan Day 1, week1- Scan Day 2, week 4)

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, as determined by a comprehensive physical examination and approval of the study physician males or females who smoke cigarettes, ages 18-60. Smoke ≥ 6 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. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), the Nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection or complete abstinence. Provide voluntary informed consent. Must be able to read. [Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.] Intelligence quotient of ≥ 80. Exclusion Criteria: History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. Current Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnoses other than nicotine dependence. Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (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. History of psychosis. Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour. Current diagnosis of or treatment within the last 3 months for alcohol dependence. Current use of any smoking cessation treatments such as Zyban, Chantix, Wellbutrin, patch, gum, inhaler, electronic cigarettes, herbal preparations. Vision problems that cannot be corrected with glasses. Weight exceeding 300 pounds [Imaging data acquisition is impaired with high weight individuals]. History of stroke.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresa R Franklin, Ph.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania Center for Studies of Addiction

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Baclofen Effects in Cigarette Smokers

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