Examining a unique medication for alcoholic smokers

ISRCTN ISRCTN62137064
DOI https://doi.org/10.1186/ISRCTN62137064
Secondary identifying numbers 0908000034
Submission date
15/10/2013
Registration date
29/10/2013
Last edited
29/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Lorenzo Leggio
Scientific

121 South Main St
Providence, RI
02903
United States of America

Study information

Study designBetween-subject double-blind placebo-controlled randomized clinical trial (RCT)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleExamining unique pharmacology intervention for heavy drinking alcohol dependent individuals who smoke
Study objectivesBaclofen, compared to placebo, will improve outcomes of alcohol-tobacco co-use in alcoholic smokers.
Ethics approval(s)Brown University Institutional Review Board (IRB), November 3, 2009, Study ID 0908000034, Providence, RI.
Health condition(s) or problem(s) studiedAlcohol dependence; nicotine dependence
InterventionBaclofen 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Baclofen
Primary outcome measure1. Percent (%) days abstinent from alcohol-tobacco co-use
2. Percent (%) days of alcohol-tobacco co-use
Secondary outcome measures1. 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 study start date01/04/2010
Completion date30/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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).
Key exclusion criteria1. 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.
Date of first enrolment01/04/2010
Date of final enrolment30/03/2012

Locations

Countries of recruitment

  • United States of America

Study participating centre

121 South Main St
Providence, RI
02903
United States of America

Sponsor information

ABMRF/The Foundation for Alcohol Research (USA)
Research organisation

1122 Kenilworth Drive
Suite 407
Baltimore, MD
21204
United States of America

Website http://www.abmrf.org/
ROR logo "ROR" https://ror.org/03pbfnd97

Funders

Funder type

Research organisation

ABMRF/The Foundation for Alcohol Research (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
AMBRF/Foundation for Alcohol Research, Alcoholic Beverage Medical Research Foundation/The Foundation for Alcohol Research
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan