Plain English Summary
Background and study aims
Alcohol and nicotine use frequently happen at the same time and approximately half of the alcoholic population smokes. Spontaneous smoking cessation is infrequent among alcoholics, and up to 75% of alcoholic smokers would require treatment for both dependencies. However, there is presently no approved single treatment that can address both addictions concurrently. The main aim of this study is to investigate if a medication called baclofen may help alcoholic smokers to reduce alcohol and tobacco consumption at the same time.
Who can participate?
Individuals who are heavy drinkers and heavy smokers and dependent on both alcohol and nicotine.
What does the study involve?
The study involves outpatient visits during a four-month period of time. Interested individuals receive a comprehensive medical and psychological screening to make sure they satisfy the required criteria of the study and that it is safe taking the study medication.
Eligible participants are randomly allocated to one of two groups. They are asked to take the study medication (baclofen or a dummy drug called placebo) four times a day for 12 consecutive weeks. They are also asked to come back for outpatient visits once a week during the first month, then once every other week during the second and third month, and finally approximately one month after the medication is stopped for a brief follow-up. At each visit, participants are asked to fill out assessments and they also receive a brief behavioral intervention focused on alcohol- and smoking-related problems.
What are the possible benefits and risks of participating?
Participation to this study may help participants to cut down their alcohol drinking and smoking. The main risks are those associated with the use of a medication, including possible increased sedation, sleepiness, nausea and fatigue.
Where is the study run from?
Participants were recruited via advertisements in public transportation and mass media, referrals from other clinics, and by word of mouth. The study was conducted at Brown University and Roger Williams Medical Center, Providence, RI, USA
When is the study starting and how long is it expected to run for?
The study ran from April 2010 to March 2012.
Who is funding the study?
The study was funded by a non-profit organization called ABMRF/The Foundation for Alcohol Research.
Who is the main contact?
Professor Lorenzo Leggio
Lorenzo_Leggio@Brown.edu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0908000034
Study information
Scientific title
Examining unique pharmacology intervention for heavy drinking alcohol dependent individuals who smoke
Acronym
Study hypothesis
Baclofen, compared to placebo, will improve outcomes of alcohol-tobacco co-use in alcoholic smokers.
Ethics approval
Brown University Institutional Review Board (IRB), November 3, 2009, Study ID 0908000034, Providence, RI.
Study design
Between-subject double-blind placebo-controlled randomized clinical trial (RCT)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Alcohol dependence; nicotine dependence
Intervention
Baclofen 80mg/day (20 mg q.i.d.) versus placebo (contains riboflavin 25mg per each capsule as a marker of compliance and microcrystalline cellulose as filler).
Oral administration, 12-week treatment, 4-week follow-up
Intervention type
Drug
Phase
Not Applicable
Drug names
Baclofen
Primary outcome measures
1. Percent (%) days abstinent from alcohol-tobacco co-use
2. Percent (%) days of alcohol-tobacco co-use
Secondary outcome measures
1. Length of abstinence from alcohol
2. Length of abstinence from smoking
3. Craving for alcohol measured using Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS) at screening (week 00), baseline/randomization day (week 01), during the intervention (weeks 02, 03, 04, 06, 08, 10, 12) and the follow-up (week 16).
4. Craving for smoking measured using Questionnaire on Smoking Urges-Brief (QSU-B) and a smoking Visual Analogue Scale (S-VAS) at screening (week 00), baseline/randomization day (week 01), during the intervention (weeks 02, 03, 04, 06, 08, 10, 12) and the follow-up (week 16).
Overall trial start date
01/04/2010
Overall trial end date
30/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Between 18 and 75 years old
2. DSM-IV diagnoses of both alcohol and nicotine co-dependency, with heavy use of alcohol (men ≥ 5 Standard Drink Units [SDUs], and women ≥ 4 SDUs a day) and cigarettes (≥10 cigarettes per day) on average during the last 90 days before screening
3. Interested in receiving treatment for both drinking and smoking (either reducing or stopping both substances; or reducing one substance and stopping the other).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Current (i.e. past year) DSM-IV diagnosis of dependence on any psychoactive substance other than alcohol and nicotine
2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychosis
3. Past year diagnosis of major depression, anxiety disorders, eating disorders
4. Risk of suicide (e.g. active plan, or recent attempt in last year)
5. Positive urine drug screen at baseline for any illegal substance other than marijuana
6. Important alcohol withdrawal symptoms, as assessed by a Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score >10
7. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure
8. Participation in any research study for alcoholism and/or smoking treatment within 3 months prior to signing the consent document
9. Pharmacological treatment with naltrexone, acamprosate, topiramate, disulfiram, nicotine replacement, bupropion, varenicline within 1 month prior to randomization
10. Current use of psychotropic medications or medications that interfere with the metabolism of BACL, history of allergy to BACL or medical contraindications to take BACL
11. Severe medical diseases, such as cancer, cirrhosis, chronic kidney failure, chronic neurological disorders
12. Females who were of child bearing potential and not practicing effective birth control.
Recruitment start date
01/04/2010
Recruitment end date
30/03/2012
Locations
Countries of recruitment
United States of America
Trial participating centre
121 South Main St
Providence, RI
02903
United States of America
Sponsor information
Organisation
ABMRF/The Foundation for Alcohol Research (USA)
Sponsor details
1122 Kenilworth Drive
Suite 407
Baltimore
MD
21204
United States of America
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
ABMRF/The Foundation for Alcohol Research (USA)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary