Cocaine DependencePhase 2NCT01176591
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
A Phase 2 study of Cocaine Dependence and Alcohol Dependence, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Dependence, Alcohol Dependence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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).
- An unacceptable liver panel or liver function tests (LFTs) that may be indicative of hepatic dysfunction.
- Clinical laboratory tests (e.g., complete blood count (CBC), blood chemistries, urinalysis) outside normal limits, as determined by the study PI.
- History of significant heart disease or dysfunction (e.g., an arrhythmia which required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
- Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
- History of chest pain associated with cocaine use that prompted a visit to a physician.
- Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Human Behavioral Pharmacology Laboratory (HBPL) Study of the Impact of the NK1 Antagonist Aprepitant (Emend®) on Stress-Induced Cocaine and Alcohol Craving
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.
Read the detailed description
Non treatment seeking subjects with DSM IV cocaine and alcohol dependence were included. Subjects received double-blind acute dosing of 80 mg of aprepitant (Emend) at session start, or matched placebo. During each session subjects were exposed to one of two types of stressors, one stressor per session, presented in counterbalanced order across participants. The Physiologic stress was the cold-pressor task. Subjects immersed their hand in cold water for up to 3 minutes. The psychological stress was the Trier Social Stress Test it was completed in 25 minutes: 5 min audio taped instructions, 10 min to mentally prepare for their performance tasks, 5 min to complete a public speaking task and 5 min to complete a mental arithmetic task. Outcome measures included: Alcohol Craving measured by visual analog scale, cocaine craving measured by visual analog scale and The Multiple Choice Procedure. Each assessment was done during study screening, and then at multiple times during each study session.
- Conditions
- Cocaine Dependence, Alcohol Dependence
- Being tested
- Placebo session 1, Aprepitant session 2, Placebo session 1, Placebo session 2
- Keywords
- Cocaine and alcohol dependence (CAD)
- Medical subject headings
- Cocaine-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo session 1, Aprepitant session 2Drug
Also called Aprepitant
placebo in session 1, Aprepitant 80 mg in session 2, oral administration.
Placebo session 1, Placebo session 2Drug
Also called Placebo
Placebo, one per session, oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo session 1, Placebo session 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Session 2
Secondary outcomes (2)
Multiple Choice Procedure (MCP) 1
The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values. The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine. MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.
Measured: Session 1
Multiple Choice Procedure (MCP) 2
The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values. The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine. MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.
Measured: Session 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kyle M Kampman, MD, Study director, Perelman School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176591
- Sponsor's protocol ID
- 811184
- Other IDs
- K01DA025073
- Status last verified
- Jul 2020
- First submitted
- 4 Aug 2010
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Behavioral Pharmacology Laboratory (HBPL) Study of the Impact of the NK1 Antagonist Aprepitant (Emend®) on Stress-Induced Cocaine and Alcohol Craving
- ClinicalTrials.gov ID
- NCT01176591
- Acronym / sponsor ID
- 811184
- Conditions
- Cocaine Dependence, Alcohol Dependence
- Keywords
- Cocaine and alcohol dependence (CAD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non treatment seeking subjects with DSM IV cocaine and alcohol dependence were included. Subjects received double-blind acute dosing of 80 mg of aprepitant (Emend) at session start, or matched placebo. During each session subjects were exposed to one of two types of stressors, one stressor per session, presented in counterbalanced order across participants. The Physiologic stress was the cold-pressor task. Subjects immersed their hand in cold water for up to 3 minutes. The psychological stress was the Trier Social Stress Test it was completed in 25 minutes: 5 min audio taped instructions, 10 min to mentally prepare for their performance tasks, 5 min to complete a public speaking task and 5 min to complete a mental arithmetic task. Outcome measures included: Alcohol Craving measured by visual analog scale, cocaine craving measured by visual analog scale and The Multiple Choice Procedure. Each assessment was done during study screening, and then at multiple times during each study session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Session 1, Aprepitant Session 2 | Experimental | Drug: Placebo session 1, Aprepitant session 2Participants 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. |
| Placebo Session 1, Placebo Session 2 | Placebo comparator | Drug: Placebo session 1, Placebo session 2Participants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo session 1, Aprepitant session 2Also: Aprepitantplacebo in session 1, Aprepitant 80 mg in session 2, oral administration. | Drug | Placebo Session 1, Aprepitant Session 2 |
| Placebo session 1, Placebo session 2Also: PlaceboPlacebo, one per session, oral administration | Drug | Placebo Session 1, Placebo Session 2 |
Primary outcome
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 1
Time frame: Session 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.
Alcohol Craving as Measured by the Visual Analog Scale (VAS) 1
Time frame: Session 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.
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 2
Time frame: Session 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.
Alcohol Craving as Measured by the Visual Analog Scale (VAS) 2
Time frame: Session 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.
2 secondary outcomes
Multiple Choice Procedure (MCP) 1
Time frame: Session 1
Multiple Choice Procedure (MCP) 2
Time frame: Session 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle M Kampman, MD study director
Perelman School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Cocaine Dependence and Alcohol Dependence, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 1 (time frame: Session 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.