Topiramate for Alcohol and Cocaine Dependence

NCT00167245 | Completed Phase 2 Results DMC

• 2 other identifiers: 801385R01AA014657
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholism; Cocaine Dependence

Keywords

Topiramate; alcoholism; cocaine dependence

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial

  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.

  Last 3 weeks of 13 week trial

• Number of Heavy Drinking Days

  Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women

  13 weeks

Secondary Outcomes (2)

• Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.

  13 weeks

• The Penn Alcohol Craving Scale

  13 weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

topiramate capsules dose titrated up to 300 mg daily

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

placebo capsules identical in appearance to the topiramate capsules

Drug: placebo

Interventions

Topiramate DRUG

300mg/day for 13 weeks

Also known as: topamax

Topiramate

placebo DRUG

placebo pills

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyle Kampman: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism; Cocaine-Related Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

The total number of subjects was relatively small and thus the results should be considered preliminary. The study drop-out rate was formidable, though it was comparable with most trials involving cocaine-dependent patients.

Results Point of Contact

• Title: Dr. Kyle Kampman
• Organization: University of Pennsylvania

kampman@mail.med.upenn.edu

2152223200

Study Officials

• Kyle M Kampman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2020
• Results First Posted: September 1, 2014

Record last verified: 2019-07

Locations

US (1)