Cocaine Dependence | Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Cocaine Dependence research study
What is the primary objective of this study?
The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Who is eligible to participate?
Inclusion Criteria: - Men and women between the ages of 18-60 who meet DSM-IV criteria for cocaine dependence. - Used cocaine at least 9 days in the past 28 days with at least weekly cocaine use. - Able of giving informed consent and capable of complying with study procedures. Exclusion Criteria: - Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. - Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication the patient is taking is compatible with the study medication (mixed amphetamine salts plus topiramate) and does not entail serious risk of adverse effects from the drug interactions. Individuals cannot be on any psychostimulants or other contraindicated medications. - Individuals with a history of seizures or unexplained loss of consciousness - History of allergic reaction to candidate medications (amphetamine or topiramate). - Individuals with significant current suicidal risk. - Women who are pregnant, nursing, or failure in sexually active female patients to use adequate contraceptive methods. - Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, DBP> 90,or HR > 100 when sitting quietly), acute hepatitis(patients with chronic mildly elevated transaminases < 3x upper limit of normal are acceptable), or uncontrolled diabetes. - Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and family history of ventricular tachycardia/sudden death. - Individuals with use of carbonic anhydrase inhibitors - History of glaucoma - History of kidney stones - Use of drugs that may be additive to the bicarbonate lowering effects of topiramate - Body Mass Index (BMI) < 18kg/m2 - History of failure to respond to a previous adequate trial of either of the candidate medications for cocaine dependence - Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention - Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties,etc.) to participate in substance abuse treatment program - Individuals with a current history (within the past 6 months) of amphetamine abuse or dependence including amphetamines such as methamphetamine and MDMA.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:TopiramateTopiramate 100 mg bid.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Adderall-ER and TopiramateAdderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
PlaceboPlacebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Start Date: July 2013
Completed Date: June 2017
Phase: Phase 2/Phase 3
Primary Outcome: Three Weeks of Cocaine Abstinence at End of Study
Secondary Outcome: Any Three Consecutive Weeks of Abstinence During Study
Study sponsors, principal investigator, and references
Principal Investigator: Frances Levin, M.D.
Lead Sponsor: New York State Psychiatric Institute
Collaborator: National Institute on Drug Abuse (NIDA)