VIVITROL as a Treatment for Cocaine and Alcohol Dependence

NCT00777062 | Completed Phase 2 Results DMC

• 3 other identifiers: 8086415P50DA012756-10DPMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence

Conditions

Cocaine Dependence; Alcohol Dependence

Keywords

alcohol; cocaine; addiction; alcoholism; substance dependence; substance abuse

Outcome Measures

Primary Outcomes (2)

• Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.

  Percentage of subjects with no cocaine use for at least 3 weeks

  8 week medication phase

• Time Line Follow Back -Reported Days of Abstinence From Drinking

  Percentage of participants who were abstinent from drinking

  8 week medication phase

Study Arms (2)

1

EXPERIMENTAL

VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6

Drug: VIVITROL (Naltrexone extended-release injectable suspension)

2

PLACEBO COMPARATOR

Placebo injection, 380 mg injection at the start of weeks 2 and 6.

Drug: Placebo

Interventions

VIVITROL (Naltrexone extended-release injectable suspension) DRUG

VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.

Also known as: Vivitrol

1

Placebo DRUG

Placebo injection at the start of weeks 2 and 6.

2

Eligibility Criteria

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

You may qualify if:

• Males and females, 18 to 65 years old.
• Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
• Meets DSM-IV criteria for Alcohol Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
• Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
• drank within 30 days of intake day,
• reports a minimum of XX standard alcoholic drinks in a consecutive 30-day period over the 90-day period prior to starting intake, and
• has 2 or more days of heavy drinking
• In the past 30 days prior to consent, used no less than $ of cocaine.
• Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
• Understands and signs the informed consent.
• Three consecutive days of abstinence from alcohol, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight.

You may not qualify if:

• Positive urine drug screen and/or current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, alcohol, or nicotine dependence, as determined by the SCID.
• Concomitant treatment with psychotropic medications, including opioid analgesics.
• Patients mandated to treatment based upon a legal decision or as a condition of employment.
• Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI).
• Taken any investigational medication within the past 30 days.
• History within the six months prior to randomization of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson-White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure). These are to be reviewed on a case-by-case basis: EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests \[LFTs\] \<3 x ULN are acceptable).
• Known hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.
• Patients with any serious illnesses that may require hospitalization during the study.
• Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
• Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator.
• Current physiological opioid dependence.
• Experiencing acute opiate withdrawal.
• Likely to receive scheduled surgery, which may require treatment with opioid analgesics.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Alkermes, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• University of Pennsylvania Center for the Studies of Addiction

MeSH Terms

Conditions

Cocaine-Related Disorders; Alcoholism; Behavior, Addictive; Substance-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Results Point of Contact

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

kampman@mail.med.upenn.edu

215-222-3200

Study Officials

• Helen Pettinati, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2013
• Last Updated: January 26, 2018
• Results First Posted: January 29, 2014

Record last verified: 2018-01

Locations

US (1)