Baclofen Effects on Smoking Urge and Withdrawal
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nicotine Use Disorder; Nicotine Dependence; Smoking; Tobacco Use Disorder
Intervention: Baclofen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Damaris Rohsenow, PhD, Principal Investigator, Affiliation: VA Medical Center, Providence
Overall contact:
Rebecca R Swagger, MA, Phone: (401) 273-7100, Ext: 3872, Email: rebecca.swagger@va.gov
Summary
The purpose of this study is to determine whether baclofen is effective in reducing smoking
urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.
Clinical Details
Official title: Baclofen Effects on Smoking Urge and Withdrawal
Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Three measures are equally important: 1) Total score on Questionnaire of Smoking Urges; 2) Minnesota Nicotine Withdrawal Scale, 3) Number of choices for cigarette puffs vs. financial incentive in a behavioral economics procedure.
Secondary outcome: Nicotine self-administration as quantified by salivary cotinine boost during a behavioral self-administration task.
Detailed description:
OBJECTIVES: The long-term objective of this research program is to improve treatments for
tobacco smokers by investigating the effects of medications on self-reported and
psychophysiological responses to smoking cues and on behavioral-economic measures of smoking
reinforcement during a period of tobacco deprivation. The specific objectives of the present
application are to investigate the dose-response effects of baclofen (a GABA-B agonist), 1)
on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices
for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours
of smoking deprivation.
RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design
with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of
baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4
hours of deprivation.
METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and
who are motivated for future smoking cessation. On Day 0, a baseline session will occur
after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be
repeated after the final medication dose has been stabilized for at least 3 days and after 4
hours of supervised smoking deprivation has occurred. Medication differences in urge and
withdrawal and in the reinforcement value of smoking cigarettes will be investigated.
Dependent measures of urge and withdrawal will be by self-report. The dependent measure of
reinforcement value is the ratio of choices for cigarette puffs versus money during a
subsequent 2-1/2 hr period. The choice procedure will clarify the relative reinforcement
value of smoking while controlling for non-specific decreases in general activity level
resulting from sedation. Nicotine self-administration during the medication period will be
quantified using saliva cotinine, as a secondary effect.
CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less
suffering and mortality and in considerable savings in health care costs associated with
cardiovascular disease, pulmonary disorders, and cancer.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Smoke at least 10 cigarettes per day for at least 6 months and considering quitting
smoking in the next 6 months-
Exclusion Criteria:
- Planning to attempt smoking cessation within the next 4 months
- Weight less than 110 lbs. or above 220 lbs.
- Use of tobacco products other than cigarettes in the previous month.
- History of: Kidney disease, uncontrolled conditions (e. g., cardiac disease, pulmonary
disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke,
brain injury, Alzheimers Disease, encephalitis, meningitis, seizure
disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder,
or Schizotypal Disorder.
- Current alcohol and/or drug use disorder as indicated by a screening questionnaire,
past treatment for alcohol or substance use problems unless in remission(clean and
sober for past year or more) or intention to seek treatment in the next 6 months for
alcohol or substance use problems.
- For women: Pregnancy, nursing, not using a reliable form of birth control.
- Allergy to baclofen, Lioresal, or Kemstro.
- Taking the following medications: antidepressants(excluding SSRIs), bupropion,
phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers,
beta blockers.
- Lives with someone enrolled in the study.
Locations and Contacts
Rebecca R Swagger, MA, Phone: (401) 273-7100, Ext: 3872, Email: rebecca.swagger@va.gov
VA Medical Center, Providence, Providence, Rhode Island 02908, United States; Recruiting
Regina Correa-Murphy, Phone: 401-273-7100, Ext: 3478, Email: regina.correa-Murphy@va.gov
Robert M Swift, MD PhD AB, Phone: (401) 457-3066, Email: Robert.Swift@va.gov
Damaris Rohsenow, PhD, Principal Investigator
Additional Information
Starting date: December 2005
Ending date: December 2008
Last updated: July 31, 2008
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