Smoking addiction MedDRA version: 12.0 Level: LLT Classification code 10043903 Term: Tobacco abuse
Conditions
Interventions
Trade Name: LIORESAL
Pharmaceutical Form: Tablet
INN or Proposed INN: Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placeb
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women between the ages of 18 and 60 meeting DSM-IV criteria for actively smoking nicotine dependence 2. Able to understand and sign written informed consent. 3. Express a desire to achieve abstinence or to greatly reduce cigarettes consumption. 4. Must have a stable residence and be able to identify an individual who could locate subject if needed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g ., kidney impairment, unstable hypertension, hypotension, diabetes mellitus, BPCO). 2. Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than cannabis and/or alcohol abuse. All addictions (including alcohol-dependence) will be excluded. 3. Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, or stimulants. However, subjects who have been on stable doses of the antidepressants fluoxetine, sertraline, paroxetine, citalopram, ecitalapram, trazodone or venlafaxine for two months will be eligible. 4. Concurrent use of insulin, or oral hypoglycemics. 5. AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or creatinine > ULN. 6. Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence. 7. Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal). 8. Women who are breastfeeding 9. Participation in any clinical trial within the last 60 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The effect of the drug to reduce the smoking habit (number of cigarettes used per day by the TLFB);Main Objective: to investigate the efficacy and tolerability of baclofen in tobacco smokers subjects treated for 12-weeks.;Secondary Objective: Variation of Craving for cigarettes Variation of State and Trait anxiety and of current depression Variation of food craving Variation of quality of life Variation of BMI | — |
Countries
Italy
Outcome results
None listed