A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence

NCT01680887 | Completed Phase 2 Results DMC

• 1 other identifier: 814643
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind placebo-controlled clinical trial (n = 156) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance.

Conditions

Cocaine Dependence

Keywords

Cocaine dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial

  Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.

  weeks 11,12,13 of the trial

Secondary Outcomes (1)

• Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator

  Once per week in weeks 2 through 13

Study Arms (2)

Varenicline

EXPERIMENTAL

Oral 1.0 mg BID.

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Oral 1.0 mg BID.

Drug: Placebo

Interventions

Varenicline DRUG

Also known as: Chantix

Varenicline

Placebo DRUG

Placebo

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).
• 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.

You may not qualify if:

• Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, alcohol, or nicotine dependence, as determined by the SCID.
• Subject is, in the investigator's opinion, at risk of requiring medical detoxification for alcohol dependence during the study.
• Concomitant treatment with psychotropic medications.
• Current gambling problems. This will be assessed by the patient's self-report.
• Patients mandated to treatment based upon a legal decision or as a condition of employment who will use participation in this study to fulfill to their court mandated treatment requirement.This will be assessed by the patient's self-report.
• 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).
• Use of any investigational medication within the past 30 days.
• Subject has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
• Current use of naltrexone, disulfiram, modafinil, stimulants, haloperidol, benzodiazepines or anticonvulsants.
• Known hypersensitivity to varenicline.
• Patients with known AIDS or other 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:
• barrier (diaphragm or condom) with spermicide
• intrauterine progesterone contraceptive system
• levonorgestrel implant

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• University of Pennsylvania Center for Studies of Addictions

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Kyle Kampman
• Organization: Perelman School of Medicine

kampman@pennmedicine.upenn.edu

215 746 2764

Study Officials

• Kyle M Kampman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)