Cocaine Use DisorderEarly Phase 1NCT03937986

Suvorexant and Cocaine

A Early Phase 1 study testing Suvorexant and Cocaine in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cocaine Use Disorder
What is being tested?: Suvorexant and Cocaine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2019to 30 Apr 2022
Phase: Early Phase 1
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Recent cocaine use

Who cannot join

Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
Females not currently using effective birth control
Contraindications to cocaine, methylphenidate or duloxetine

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40507

Other trials in United States

About this study

Official title: Influence of Orexin Antagonism on Motivation for Cocaine

The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Conditions: Cocaine Use Disorder
Being tested: Suvorexant, Cocaine, Placebo oral capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuvorexantDrug
The pharmacodynamic effects of suvorexant maintenance will be determined.
CocaineDrug
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
Placebo oral capsuleDrug
The pharmacodynamic effects of placebo will be determined.

Study groups in NCT03937986
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo oral capsule
Suvorexant Dose 1	Experimental	Subjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance. Receives: Drug: Suvorexant; Drug: Cocaine
Suvorexant Dose 2	Experimental	Subjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance. Receives: Drug: Suvorexant; Drug: Cocaine
Suvorexant Dose 3	Experimental	Subjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance. Receives: Drug: Suvorexant; Drug: Cocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Reinforcing Effects of Cocaine
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
Measured: 12 times over approximately 1 month inpatient admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201930 Apr 2022

First posted6 May 2019
Study start11 Jul 2019
Primary completion30 Apr 2022
Study completion30 Apr 2022

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 Use DisorderStudies of the same condition, open and under way.
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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03937986
Sponsor's protocol ID: BED IN 39
Other IDs: R01DA048617
Status last verified: Feb 2023
First submitted: 2 May 2019
Last updated: 9 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cocaine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Orexin Antagonism on Motivation for Cocaine
ClinicalTrials.gov ID: NCT03937986
Acronym / sponsor ID: BED IN 39
Conditions: Cocaine Use Disorder
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: William StoopsUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 11 Jul 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 6 May 2019 (actual)
Results: Posted 8 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Cocaine, Drug: Placebo oral capsuleSubjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Suvorexant Dose 1	Experimental	Drug: Suvorexant, Drug: CocaineSubjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance.
Suvorexant Dose 2	Experimental	Drug: Suvorexant, Drug: CocaineSubjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance.
Suvorexant Dose 3	Experimental	Drug: Suvorexant, Drug: CocaineSubjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Recent cocaine use

Key exclusion criteria (5 listed)

Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
Females not currently using effective birth control
Contraindications to cocaine, methylphenidate or duloxetine

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
SuvorexantThe pharmacodynamic effects of suvorexant maintenance will be determined.	Drug	Suvorexant Dose 1, Suvorexant Dose 2, Suvorexant Dose 3
CocaineThe pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.	Drug	Placebo, Suvorexant Dose 1, Suvorexant Dose 2, Suvorexant Dose 3
Placebo oral capsuleThe pharmacodynamic effects of placebo will be determined.	Drug	Placebo

Primary outcome

Reinforcing Effects of Cocaine
Time frame: 12 times over approximately 1 month inpatient admission.
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Included in Analysis	8	7

Primary outcome: Reinforcing Effects of Cocaine

Time frame: 12 times over approximately 1 month inpatient admission.. Mean (Standard Error). Unit: Number of Cocaine Choices

Measure	Dose Condition 1 n = 8	Dose Condition 2 n = 8	Dose Condition 3 n = 8	Dose Condition 4 n = 7	Dose Condition 5 n = 7	Dose Condition 6 n = 7	Dose Condition 7 n = 8	Dose Condition 8 n = 8	Dose Condition 9 n = 7	Dose Condition 10 n = 7	Dose Condition 11 n = 7	Dose Condition 12 n = 7
Value	1.3 (3.5)	5.0 (5.3)	8.3 (3.)	0 (0)	3.7 (8.4)	8.4 (2.7)	1.3 (3.5)	8.1 (3.7)	9.3 (1.9)	0.4 (1.1)	6.6 (4.7)	8.7 (1.9)

Adverse events

Time frame: 32 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Included in Analysis	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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.

William W Stoops, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Suvorexant and Cocaine in people with Cocaine Use Disorder, run by William Stoops 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 1 inclusion and 5 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 9 Feb 2023. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 8 Feb 2023). 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?

Reinforcing Effects of Cocaine (time frame: 12 times over approximately 1 month inpatient admission.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937986.

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 9 Feb 2023.