Basic ScienceEarly Phase 1NCT01860287

The Effects of Buprenorphine on Responses to Verbal Tasks

A Early Phase 1 study testing Buprenorphine 0.2 MG Sublingual Tablet and Buprenorphine 0.4 MG Sublingual Tablet in people with Basic Science, run by University of Chicago 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 40 yearsHealthy volunteers can take part
Conditions the study is for: Basic Science
What is being tested?: Buprenorphine 0.2 MG Sublingual Tablet and Buprenorphine 0.4 MG Sublingual Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Jan 2017
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women
ages 18-40 years
high school education
fluent in English

Who cannot join

history of adverse drug reactions
taking oral contraceptives or planning to become pregnant
taking any medications
smokers
night shift workers
drink more than 4 alcoholic or caffeinated drinks per day

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.

Conditions: Basic Science
Being tested: Buprenorphine 0.2 MG Sublingual Tablet, Placebo, Buprenorphine 0.4 MG Sublingual Tablet
Keywords: opioid, subjective, stress, buprenorphine

What participants receive

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

Buprenorphine 0.2 MG Sublingual TabletDrug
This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)
PlaceboDrug
This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo
Buprenorphine 0.4 MG Sublingual TabletDrug
This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)

Study groups in NCT01860287
Study group	Role	What they receive
Placebo group	Placebo comparator	Healthy volunteers receive placebo during session (within-subjects design). Receives: Drug: Placebo
buprenorphine (0.2 mg) group	Experimental	Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design). Receives: Drug: Buprenorphine 0.2 MG Sublingual Tablet
buprenorphine (0.4 mg) group	Experimental	Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design). Receives: Drug: Buprenorphine 0.4 MG Sublingual Tablet

What is being measured

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

Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Measured: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown

Timeline

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

Sep 2013Jan 2017

First posted22 May 2013 (estimated)
Study startSep 2013
Primary completionJan 2017
Study completionJan 2017

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 Basic ScienceStudies of the same condition, open and under way.
More trials run by University of ChicagoThe 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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860287
Sponsor's protocol ID: UCIRB-130197
Status last verified: Apr 2019
First submitted: 6 May 2013
Last updated: 1 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Buprenorphine on Responses to Verbal Tasks
ClinicalTrials.gov ID: NCT01860287
Acronym / sponsor ID: UCIRB-130197
Conditions: Basic Science
Keywords: opioid, subjective, stress, buprenorphine
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Sep 2013
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 1 Aug 2019

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: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo group	Placebo comparator	Drug: PlaceboHealthy volunteers receive placebo during session (within-subjects design).
buprenorphine (0.2 mg) group	Experimental	Drug: Buprenorphine 0.2 MG Sublingual TabletHealthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).
buprenorphine (0.4 mg) group	Experimental	Drug: Buprenorphine 0.4 MG Sublingual TabletHealthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy men and women
ages 18-40 years
high school education
fluent in English

Key exclusion criteria (6 listed)

history of adverse drug reactions
taking oral contraceptives or planning to become pregnant
taking any medications
smokers
night shift workers

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
Buprenorphine 0.2 MG Sublingual TabletThis is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)	Drug	buprenorphine (0.2 mg) group
PlaceboThis is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo	Drug	Placebo group
Buprenorphine 0.4 MG Sublingual TabletThis is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)	Drug	buprenorphine (0.4 mg) group

Primary outcome

Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Time frame: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Results and safety

Results posted to the registry on 1 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Group	18	18
0.2 Buprenorphine	15	15
0.4 mg Buprenorphine	15	15

Primary outcome: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine

Time frame: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo Group n = 18	0.2 Buprenorphine n = 15	0.4 mg Buprenorphine n = 15
Feel Drug	13.57 (2.1)	36.57 (4.5)	59.89 (1.55)
Like Drug	9.4 (1.2)	43.27 (3.6)	56.25 (4.22)
Feel High	6.0 (1.5)	27.27 (2.5)	41.69 (3.45)
Want More	4.27 (1.3)	12.47 (1.9)	21.57 (1.96)

Adverse events

Time frame: 6 days for each intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Group	0 of 18 (0%)	0 of 18 (0%)	0 of 18
0.2 Buprenorphine	0 of 15 (0%)	0 of 15 (0%)	0 of 15
0.4 mg Buprenorphine	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Harriet de Wit, Ph.D. principal investigator

University of Chicago

Jerome Jaffe, M.D. study chair

University of Maryland

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 Buprenorphine 0.2 MG Sublingual Tablet and Buprenorphine 0.4 MG Sublingual Tablet in people with Basic Science, run by University of Chicago 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 6 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 1 Aug 2019. 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 1 Aug 2019). 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?

Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine (time frame: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown). 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 NCT01860287.

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 1 Aug 2019.