HBPL Study of the Impact of the NK1 Antagonist Aprepitant

NCT01176591 | Completed Phase 2 Results DMC

• 2 other identifiers: 811184K01DA025073
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will focus on investigating the determinants and consequences of CAD via measurement of physiological, behavioral and subjective effects of physiologic and psychologic stress cues in CAD volunteers in the laboratory, and through examination of the effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study will examine the effects of the above stress cues on cocaine and alcohol craving under acute Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects.

Conditions

Cocaine Dependence; Alcohol Dependence

Keywords

Cocaine and alcohol dependence (CAD)

Outcome Measures

Primary Outcomes (4)

• Cocaine Craving as Measured on the Visual Analog Scale (VAS) 1

  The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

  Session 1

• Alcohol Craving as Measured by the Visual Analog Scale (VAS) 1

  The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

  Session 1

• Cocaine Craving as Measured on the Visual Analog Scale (VAS) 2

  The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

  Session 2

• Alcohol Craving as Measured by the Visual Analog Scale (VAS) 2

  The VAS is a 100 mm line anchored at both ends. Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving. Data are analyzed by using a ruler to determine the actual mm value of the participant mark.

  Session 2

Secondary Outcomes (2)

• Multiple Choice Procedure (MCP) 1

  Session 1

• Multiple Choice Procedure (MCP) 2

  Session 2

Study Arms (2)

Placebo Session 1, Aprepitant Session 2

EXPERIMENTAL

Participants receive placebo in session 1 and Aprepitant in session 2 of a psychological stressor presentation and receive placebo in session 1 and Aprepitant in session 2 of a physiological stressor presentation. Participants take Aprepitant (80 mg) or placebo tablets for 7 days prior to each session.

Drug: Placebo session 1, Aprepitant session 2

Placebo Session 1, Placebo Session 2

PLACEBO COMPARATOR

Participants receive placebo in session 1 and placebo in session 2 of a psychological stressor presentation and receive placebo in session 1 and placebo in session 2 of a physiological stressor presentation. Participants take placebo tablets for 7 days prior to each session. The placebo group is used for analysis purposes in order to control for any order effects found in the Experimental group.

Drug: Placebo session 1, Placebo session 2

Interventions

Placebo session 1, Aprepitant session 2 DRUG

placebo in session 1, Aprepitant 80 mg in session 2, oral administration.

Also known as: Aprepitant

Placebo Session 1, Aprepitant Session 2

Placebo session 1, Placebo session 2 DRUG

Placebo, one per session, oral administration

Also known as: Placebo

Placebo Session 1, Placebo Session 2

Eligibility Criteria

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

You may qualify if:

• Male or female and 18 years of age to 60
• The subject has used cocaine and alcohol at least once per month for at least the past year, and has used cocaine and alcohol within 30 days prior to signing consent.
• 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:

• Meets Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for current dependence on any substance other than nicotine, cocaine ,alcohol or marijuana
• Subjects who test positive on the urine drug screen for any illicit drugs other than cocaine and marijuana during screening will be allowed a single retest. Those individuals who test positive for amphetamine during screening, given that they provide a copy of a prescription, will only be included if they can safely discontinue amphetamine use for the duration of the study. Subjects will need to provide a urine free of all illicit drugs other than cocaine and marijuana at study onset to be randomized. Subjects who test positive for any drugs other than marijuana prior to a study session will be allowed a single retest and a chance to reschedule their session. If the subject tests positive for any drug other than marijuana at the retest, their participation in the study will be terminated.
• Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
• Current severe psychiatric symptoms- (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring anti-depressant therapy) as diagnosed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID), the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Rating 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 or prescription opioids.
• 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 aprepitant.
• Patients with severe concurrent illnesses such as bronchospastic disease, hyperthyroidism, diabetes mellitus.
• 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 method (diaphragm or condom) with spermicide Intrauterine progesterone contraceptive system Levonorgestrel implant Medroxyprogesterone acetate contraceptive injection, or Oral contraceptives.
• Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).

Sponsors & Collaborators

• University of Pennsylvania: 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; Alcoholism

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jennifer Plebani
• Organization: UPenn

jplebani@upenn.edu

215-222-3200

Study Officials

• Kyle M Kampman, MD

  Perelman School of Medicine

  STUDY DIRECTOR

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: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 15, 2020
• Results First Posted: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)