Topiramate for Alcohol and Cocaine Dependence (TOP2)
This study has been completed.
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
First received: September 9, 2005
Last updated: August 21, 2014
Last verified: June 2014
The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Phase II, Randomized, Double-blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence
Primary Outcome Measures:
- Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial [ Time Frame: Last 3 weeks of 13 week trial ] [ Designated as safety issue: No ]
Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.
- Number of Heavy Drinking Days [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women
Secondary Outcome Measures:
- Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2010 (Final data collection date for primary outcome measure)
Experimental: Group 1
300mg/day for 13 weeks
Other Name: topamax
Placebo Comparator: Group 2
The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3 months after completing medications).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and females, 18 years or older.
- Meets DSM(Diagnostic and Statistical Manual)-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID (Structured Clinical Interview for the DSM)-IV.
- In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell and Sobell, 1995) a. drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
- Two consecutive days of abstinence from cocaine and alcohol, determined by self-reports and confirmed by negative urine toxicology screens, a negative breathalyzer tests, and collateral report, a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan et al., 1989) score below eight,. Subjects will be encouraged to achieve 3 consecutive days of abstinence, however, subjects who have achieved 2 consecutive days of abstinence will be included with the approval of the principal investigator. We anticipate that these subjects will comprise less than 5% of total enrolled subjects. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of cocaine and alcohol abstinence prior to randomization.
- Lives a commutable distance from the Treatment Research Center (TRC) and agrees to attend all research visits including follow-up visits.
- Speaks, understands, and prints in English.
- Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent form.
- Meets DSM-IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID.
- Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- Current use of phenytoin or any drug of similar class.
- Meets DSM-IV criteria for schizophrenia or any psychotic disorder, or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
- Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels (>1.3), or elevated levels (over 3.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence, or severe renal disease, severe respiratory diseases or severe diarrhea with resulting metabolic acidosis, serum bicarbonate (< 20 milliequivalent (mEq)/L)
- History of epilepsy or seizure disorder.
- Use of an investigational medication in the 30 days prior to randomization.
- History of nephrolithiasis (kidney stones).
- History of hypersensitivity to topiramate.
- Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, and medroxyprogesterone acetate contraceptive injection).
- Current use of a carbonic anhydrase inhibitor.
- A history of glaucoma
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167245
|University of Pennsylvania, Treatment Research Center
|Philadelphia, Pennsylvania, United States, 19104 |
||Kyle M Kampman, MD
||University of Pennsylvania
No publications provided
||Kyle Kampman, Sponsor-Investigator, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 9, 2005
|Results First Received:
||April 24, 2013
||August 21, 2014
||United States: Food and Drug Administration
Keywords provided by University of Pennsylvania:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors