Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

NCT01486810 | Completed Phase 1 Results DMC

• 2 other identifiers: #6154P50DA009236-18
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.

Conditions

Cocaine Dependence

Keywords

cocaine; lisdexamfetamine

Outcome Measures

Primary Outcomes (2)

• Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.

  Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..

  during 1 week of study participation

• Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.

  The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.

  during 8 weeks of trial or length of participation

Study Arms (1)

Lisdexamfetamine and medication management

EXPERIMENTAL

Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.

Drug: Lisdexamfetamine; Behavioral: medication management

Interventions

Lisdexamfetamine DRUG

Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks

Also known as: Vyvance

Lisdexamfetamine and medication management

medication management BEHAVIORAL

All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.

Lisdexamfetamine and medication management

Eligibility Criteria

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

You may qualify if:

• Individuals must be treatment seeking
• Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence
• Used cocaine at least four days in the past month
• Individuals must be in good general health
• Individuals must be capable of giving informed consent and capable of complying with study procedures
• Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.

You may not qualify if:

• Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, any psychotic disorder other than transient psychosis due to drug abuse, or current major depressive disorder
• Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
• Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
• Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
• Individuals with current suicidal risk
• Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
• 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 \< 1.5x upper limit of normal are acceptable), or uncontrolled diabetes
• Individuals with a history of seizures, hyperthyroidism and/or glaucoma
• Individuals with a family history of sudden cardiac death
• History of allergic reaction to study medication
• Women who are pregnant or nursing
• Currently being prescribed psychotropic medication by another physician (other than sleep medication)
• Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program

Sponsors & Collaborators

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

Study Sites (1)

STARS

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Lisdexamfetamine Dimesylate; Medication Therapy Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

As this was an open label trial, future studies should evaluate lisdexamfetamine for the treatment cocaine use disorder under double-blind conditions.

Results Point of Contact

• Title: Dr. John Mariani
• Organization: New York Psychiatric Institute

John.mariani@nyspi.columbia.edu

646-774-8181

Study Officials

• John Mariani, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 24, 2019
• Results First Posted: July 11, 2018

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)