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Baclofen Effects in Cigarette Smokers (BAC)

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ClinicalTrials.gov Identifier: NCT01821560
Recruitment Status : Completed
First Posted : April 1, 2013
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Baclofen Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Baclofen Effects on Brain and Behavior in Cigarette Smokers
Study Start Date : March 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Sugar pill
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
 Drug: placebo
Active Comparator: Baclofen
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.
 Drug: Baclofen
Other Names:
  • Kemstro
  • Lioresal
  • Liofen
  • Gablofen
  • Beklo


Outcome Measures
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Primary Outcome Measures :
  1. Cigarettes Smoked Per Day [ Time Frame: 3 weeks (Scan Day 1, week1- Scan Day 2, week 4) ]
    Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821560


Locations
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United States, Pennsylvania
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Teresa R Franklin, Ph.D. University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] January 6, 2017

More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01821560    
Other Study ID Numbers: 817101
R01DA030394-01A1 ( U.S. NIH Grant/Contract )
PA Depart of Health ( Other Grant/Funding Number: CURE (Commonwealth Universal Research Enhancement) Program )
First Posted: April 1, 2013    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Keywords provided by University of Pennsylvania:
Nicotine Addiction
fMRI
Baclofen
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
 Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action