Topiramate for Alcohol and Cocaine Dependence (TOP2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00167245
First received: September 9, 2005
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Alcoholism
Cocaine Dependence
Drug: Topiramate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Days abstinent from drinking and frequency of heavy drinking days as measured by the Time Line Follow-Back during the medication/placebo treatment phase, compared to placebo-treated subjects. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Fewer days of cocaine use as measured by the Time Line Follow Back and confirmed by urine drug screen during the medication/placebo treatment phase, compared to placebo-treated subjects. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

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 ]

Enrollment: 170
Study Start Date: September 2004
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
topiramate
Drug: Topiramate
300mg/day for 13 weeks
Other Name: topamax
Placebo Comparator: Group 2 Drug: placebo
placebo pills

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and females, 18 years or older.
  • Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-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 TRC and agrees to attend all research visits including follow-up visits.
  • Speaks, understands, and prints in English.

Exclusion Criteria:

  • 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 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
  Contacts and Locations
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

Locations
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Kyle Kampman
Investigators
Principal Investigator: Kyle M Kampman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Kyle Kampman, Sponsor-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00167245     History of Changes
Other Study ID Numbers: 801385, R01AA014657
Study First Received: September 9, 2005
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Topiramate
alcoholism
cocaine dependence

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Topiramate
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 20, 2014