Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement

NCT01143857 | Withdrawn Phase 2 DMC

• 2 other identifiers: 810580K01DA025073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cocaine use, abuse and dependence is a public health problem that is directly responsible for hundreds of billions of dollars in health care expenditures per year. Relapse rates to cocaine use are high, creating a pressing need to develop effective therapies for cocaine dependence. The proposed research will focus on investigating the determinants and consequences of cocaine dependence via measurement of physiological, behavioral and subjective effects of acute doses of cocaine in healthy non-drug dependent human volunteers in the laboratory, and through examination of the effects of pharmacotherapies on the above effects of cocaine. This study will examine cocaine-derived reinforcement under week-long sub-chronic varenicline (Chantix) dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects. Subjects will be screened and consented into the study at the Treatment Research Center (TRC). Study visits where behavioral and physiological outcome data will be obtained will be conducted at the Clinical and Translational Research Center (CTRC) of the Hospital of the University of Pennsylvania. Subjects will be outpatients for this trial, with CTRC sessions scheduled at least one week apart.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Varenicline's impact on reinforcing effects of cocaine

  The primary aim of this study is to examine what impact sub-chronic dosing with varenicline has on the subjective and reinforcing effects of cocaine and on cocaine self-administration in cocaine experienced individuals.

  6 weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Varenicline

Interventions

Varenicline DRUG

Varenicline 2.0 mg/day or Placebo

Placebo; Varenicline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, 18 to 60 years old.
• Recreational users of cocaine reporting at least six instances of cocaine use in the past 12 months and at least one use in the past 30 days.
• 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 nicotine dependence, as determined by the Structured Clinical Interview for the DSM (SCID).
• Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring anti-depressant therapy) as diagnosed using the SCID, the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Ration Scale for Depression (HAM-D).
• Individuals scoring \> 10 on the Hamilton Rating Scale for Depression (HAM-D).
• Use of any investigational medication within the past 30 days.
• Concomitant treatment with psychotropic medications.
• Concomitant use of any one of the following drugs or classes of drugs:
• Reserpine
• Verapamil
• theophylline,
• trimethoprim,
• cimetidine,
• haloperidol,
• benzodiazepines, or
• antiepileptic drugs (AEDs).
• Patients with a known hypersensitivity to varenicline.

Sponsors & Collaborators

• Jennifer Plebani: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)