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Intranasal challenge drug

Phase 3

Heroin Dependence | Small molecule | Other |Indivior Pharmaceuticals, Inc.|Last Updated: Sep 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Intranasal challenge drug · 1 trial · 1 indication

Phase 3 1
NCT01760473Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/NaloxoneHeroin Dependence
COMPLETED27 Analytics
PHASE3COMPLETED
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
Heroin DependenceUnlock trial analytics

Study Endpoints

Primary Endpoints

Drug Self-administration
Throughout the testing sessions (approximately 9 weeks).

The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.

Secondary Endpoints

SOWS
Throughout the testing sessions (approximately 9 weeks).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Bup 8EXPERIMENTALIntranasal challenge drug: 8 mg of Buprenorphine administered intranasally.
Bup 16EXPERIMENTALIntranasal challenge drug: 16 mg of Buprenorphine administered intranasally.
Bup/Nal 8/2EXPERIMENTALIntranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.
Bup/Nal 8/8EXPERIMENTALIntranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.
Bup/Nal 8/16EXPERIMENTALIntranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.
Bup/Nal 16/4EXPERIMENTALIntranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.
HeroinACTIVE_COMPARATORIntranasal challenge drug: 24 mg of heroin administered intranasally.
PlaceboSHAM_COMPARATORIntranasal challenge drug: Intranasal lactose powder.
Naloxone 4 mgACTIVE_COMPARATORIntranasal challenge drug: Intranasal Naloxone 4mg.

Interventions

NameTypeDescription
Intranasal challenge drugDRUGEach of the experimental challenge drugs were administered intranasally to all participants in random order.
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Eligibility Criteria

Age Range21 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * DSM IV criteria for heroin dependence * No major mood, psychotic, or anxiety disorder * Physically healthy * Able to perform study procedures * 21-45 years of age * Normal body weight * Current use of opioids in amounts and/or frequencies that meet or exceed those used in the ...

Countries:United States
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Frequently asked questions about Intranasal challenge drug

What is Intranasal challenge drug used for?

Intranasal challenge drug is an investigational small molecule being studied for the treatment of heroin dependence. It is being developed by Indivior Pharmaceuticals, Inc. (INDV) and is currently in Phase 3 clinical development. The drug is administered intranasally and is being evaluated in a clinical trial setting.

What does Intranasal challenge drug target?

The specific molecular target of Intranasal challenge drug is not disclosed in the available information. The drug is being studied for its effects on heroin dependence, but the precise mechanism of action has not been specified. It is a small molecule modality developed by Indivior Pharmaceuticals, Inc.

Who makes Intranasal challenge drug?

Intranasal challenge drug is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker symbol INDV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with heroin dependence.

What phase is Intranasal challenge drug in?

Intranasal challenge drug is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of heroin dependence, and its clinical trial program includes a completed Phase 3 study.

What clinical trials is Intranasal challenge drug in?

Intranasal challenge drug has one completed clinical trial, identified by the National Clinical Trial number NCT01760473. This Phase 3 study, titled 'Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone,' enrolled 27 participants with heroin dependence in the United States. The trial was randomized, double-blind, and active-controlled.

Is Intranasal challenge drug the same as buprenorphine?

Intranasal challenge drug is being studied in comparison to buprenorphine and buprenorphine/naloxone in a clinical trial. The trial title suggests the drug may be related to buprenorphine, but the specific identity of Intranasal challenge drug is not explicitly stated. It is an investigational drug developed by Indivior Pharmaceuticals.