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Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Adderall-ER (Drug); Topiramate (Drug); Placebo (Other)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Frances Levin, M.D., Principal Investigator, Affiliation: Columbia University
Kyle Kampman, MD, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Elizabeth Martinez, Phone: 212-923-3031, Email: martine@nyspi.columbia.edu

Summary

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.

Clinical Details

Official title: Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Three weeks of Cocaine abstinence

Secondary outcome: Proportion of negative urine samples

Detailed description: The investigators hypothesize that the combination of an agent that increased baseline dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release (topiramate) will improve dopamine regulation and be associated with improved cocaine use outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and all other study inclusion and exclusion criteria will be assigned to the 14-week double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER and topiramate will promote cocaine abstinence. Participants who are randomized to the combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks) and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the trial. During week 14, participants will be tapered off both medications. All participants will receive a supportive behavioral treatment that emphasizes study procedure adherence. Starting in week one, all patients will receive incentives for compliance with study procedures on an escalating reinforcement schedule similar to that developed previously and not contingent on urine results. The purpose of the lead-out is to blind patients to the exact point of medication discontinuation and to provide naturalistic data on the effects of medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what happens to cocaine use after treatment discontinuation.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Elizabeth Martinez, Phone: 212-923-3031, Email: martine@nyspi.columbia.edu

STARS, New York, New York 10032, United States; Recruiting
Elizabeth Martinez, Phone: 212-923-3031, Email: martine@nyspi.columbia.edu
Frances Levin, M.D., Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Elizabeth Mahoney, MA, Phone: 215-243-9959, Email: emaho@mail.med.upenn.edu
Elizabeth Mahoney, M.A., Phone: 215-222-3200, Ext: 150
Kyle Kampman, MD, Principal Investigator

Additional Information

stars website

Starting date: July 2013
Last updated: March 30, 2015

Page last updated: August 23, 2015

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