Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

NCT01811940 | Completed Phase 2 Results DMC

• 2 other identifiers: #66981U01DA033310-01A1
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cocaine Dependence

Keywords

cocaine dependence; adderall; topiramate

Outcome Measures

Primary Outcomes (1)

• Three Weeks of Cocaine Abstinence at End of Study

  The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.

  assessed during 14 weeks of trial, presented for last 3 weeks

Secondary Outcomes (1)

• Any Three Consecutive Weeks of Abstinence During Study

  14 weeks of study or length of study participation

Study Arms (2)

Adderall-ER and Topiramate

EXPERIMENTAL

Adderall-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.

Drug: Adderall-ER; Drug: Topiramate

Placebo

PLACEBO COMPARATOR

Placebo 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.

Other: Placebo

Interventions

Adderall-ER DRUG

MAS-ER 60mg/day

Also known as: Adderall extended release (MAS-ER)

Adderall-ER and Topiramate

Topiramate DRUG

Topiramate 100 mg bid.

Also known as: Topamax

Adderall-ER and Topiramate

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

STARS

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• stars website

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Frances R. Levin, M.D.
• Organization: NYSPI

Frances.levin@nyspi.columbia.edu

646-774-6137

Study Officials

• Frances Levin, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

• Kyle 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 24, 2019
• Results First Posted: October 12, 2018

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)