Skip to main content
OpenTrials
Completed

NCT Number: NCT01821560

Baclofen Effects in Cigarette Smokers

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baclofen

Drug

Other names: Kemstro, Lioresal, Liofen, Gablofen, Beklo

Placebo

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

Baclofen Effects on Brain and Behavior in Cigarette Smokers

Acronym: BAC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2013
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.