DepressionBEDNCT02659787
Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology
A study testing 0.2mg Buprenorphine in people with Depression, run by University of Chicago at 1 site in United States.
Trial summary
This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on depressed mood in a healthy young adults with a range of depressive symptomatology. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- 0.2mg Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Apr 2017
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers
- High school education
- Fluency in English
- BMI between 19 and 30
Who cannot join
- Medical conditions contraindicating study participation
- Regularly medication use
- Current or past opioid abuse or dependence
- Current or past drug or alcohol dependence
- Psychiatric illness
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on depressed mood in a healthy young adults with a range of depressive symptomatology.
Read the detailed description
It has been shown that opioid analgesics, particularly the mu-opioid partial agonist buprenorphine, have anti-depressant properties in laboratory animal models. In humans, rates of prescription opioid abuse are significantly higher in patients with depression. This suggests that individuals with negative mood states (e.g., depressive states) may respond more positively to opioid drugs. A handful of small studies in in humans have suggested that buprenorphine reduces symptoms of depression in patients who did not respond to standard anti-depressants, and laboratory studies have shown buprenorphine may reduce responses to some types of negative stimuli and enhance responses to positive stimuli. However, a controlled laboratory study assessing potential anti-depressant effects of an opioid medication has never been conducted. In this project, the investigators propose to examine depressive symptomatology as a predictor of subjective mood responses to buprenorphine, using two measures; i) self-reported depressive symptomatology as measured by the Beck Depression Inventory (BDI-II), and ii) physiological indices of depressive symptomatology as measured by heart rate variability. Reduced heart rate variability has been shown to be associated with depression, and such a physiological measure may allow for the detection of more subtle effects than would a self-report questionnaire alone. Healthy volunteers (N=60) will first complete the BDI and provide baseline measures of heart rate variability. Then they will attend two laboratory sessions, at which they will receive placebo or 0.2mg buprenorphine. The investigators have tested these low doses of buprenorphine in previous studies, and they produce measurable changes in mood and behavior in healthy volunteers. The investigators will collect measures of mood and physiological drug response (pupillometry, heart rate, and blood pressure) at regular intervals throughout each session, and will then examine their baseline indices of depressive symptomatology in relation to responses to the drug. The central hypothesis is that individuals with greater self-reported depressive symptoms and lower heart rate variability will experience the greatest enhancement of mood in response to buprenorphine. It is expected that this work will provide a better understanding of which individuals are most likely to experience positive mood effects in response to opioid drugs, and may therefore be at-risk for developing an opioid use disorder. Furthermore, it may lay the foundation for future research in the development of novel opioid-based treatments for depression.
Design: The study will use a 3-session within-subjects double-blind design in which participants will receive single doses of buprenorphine (0, 0.2 mg sublingual) in randomized order. All screening, orientation, and study session procedures will take place in the Human Behavioral Pharmacology Laboratory suite in the L4 wing of 5841 S. Maryland Ave.
Drug and Doses: Investigators will administer placebo, 0.2 mg buprenorphine (Temgesic) via sublingual tablet in counterbalanced order under double-blind conditions. These tablets dissolve within 5-8 minutes. This drug has been approved for treatment of severe pain. The onset of action after sublingual administration is 30 minutes, with a peak plasma concentration at 1/5-2 hours and a half-life of 5 hours. The dose of buprenorphine are very low, and the average maintenance dose for opioid abusers is 8 mg. Doses will be separated by at least 72 hours.
- Conditions
- Depression
- Being tested
- 0.2mg Buprenorphine, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2mg BuprenorphineDrug
Sublingual buprenorphine tablets (0.2mg)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose buprenorphine | Active comparator | Subjects all receive placebo, 0.2 mg buprenorphine in crossover design Receives: Drug: 0.2mg Buprenorphine |
| Placebo | Placebo comparator | Subjects all receive placebo, 0.2 mg buprenorphine in crossover design Receives: Drug: Placebo |
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 Response 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: 0 through 3 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659787
- Sponsor's protocol ID
- 14-0170
- Acronym
- BED
- Status last verified
- Apr 2019
- First submitted
- 13 Jan 2016
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Falcon E, Maier K, Robinson SA, Hill-Smith TE, Lucki I. Effects of buprenorphine on behavioral tests for antidepressant and anxiolytic drugs in mice. Psychopharmacology (Berl). 2015 Mar;232(5):907-15. doi: 10.1007/s00213-014-3723-y. Epub 2014 Sep 3.
PubMed 25178815Sullivan MD, Edlund MJ, Steffick D, Unutzer J. Regular use of prescribed opioids: association with common psychiatric disorders. Pain. 2005 Dec 15;119(1-3):95-103. doi: 10.1016/j.pain.2005.09.020. Epub 2005 Nov 17.
PubMed 16298066Karp JF, Butters MA, Begley AE, Miller MD, Lenze EJ, Blumberger DM, Mulsant BH, Reynolds CF 3rd. Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults. J Clin Psychiatry. 2014 Aug;75(8):e785-93. doi: 10.4088/JCP.13m08725.
PubMed 25191915Nyhuis PW, Gastpar M, Scherbaum N. Opiate treatment in depression refractory to antidepressants and electroconvulsive therapy. J Clin Psychopharmacol. 2008 Oct;28(5):593-5. doi: 10.1097/JCP.0b013e31818638a4. No abstract available.
PubMed 18794671Bodkin JA, Zornberg GL, Lukas SE, Cole JO. Buprenorphine treatment of refractory depression. J Clin Psychopharmacol. 1995 Feb;15(1):49-57. doi: 10.1097/00004714-199502000-00008.
PubMed 7714228Striebel JM, Kalapatapu RK. The anti-suicidal potential of buprenorphine: a case report. Int J Psychiatry Med. 2014;47(2):169-74. doi: 10.2190/PM.47.2.g.
PubMed 25084802Licht CM, de Geus EJ, Zitman FG, Hoogendijk WJ, van Dyck R, Penninx BW. Association between major depressive disorder and heart rate variability in the Netherlands Study of Depression and Anxiety (NESDA). Arch Gen Psychiatry. 2008 Dec;65(12):1358-67. doi: 10.1001/archpsyc.65.12.1358.
PubMed 19047522Ipser JC, Terburg D, Syal S, Phillips N, Solms M, Panksepp J, Malcolm-Smith S, Thomas K, Stein DJ, van Honk J. Reduced fear-recognition sensitivity following acute buprenorphine administration in healthy volunteers. Psychoneuroendocrinology. 2013 Jan;38(1):166-70. doi: 10.1016/j.psyneuen.2012.05.002. Epub 2012 May 30.
PubMed 22651957
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology
- ClinicalTrials.gov ID
- NCT02659787
- Acronym / sponsor ID
- BED / 14-0170
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on depressed mood in a healthy young adults with a range of depressive symptomatology.
Detailed description
It has been shown that opioid analgesics, particularly the mu-opioid partial agonist buprenorphine, have anti-depressant properties in laboratory animal models. In humans, rates of prescription opioid abuse are significantly higher in patients with depression. This suggests that individuals with negative mood states (e.g., depressive states) may respond more positively to opioid drugs. A handful of small studies in in humans have suggested that buprenorphine reduces symptoms of depression in patients who did not respond to standard anti-depressants, and laboratory studies have shown buprenorphine may reduce responses to some types of negative stimuli and enhance responses to positive stimuli. However, a controlled laboratory study assessing potential anti-depressant effects of an opioid medication has never been conducted. In this project, the investigators propose to examine depressive symptomatology as a predictor of subjective mood responses to buprenorphine, using two measures; i) self-reported depressive symptomatology as measured by the Beck Depression Inventory (BDI-II), and ii) physiological indices of depressive symptomatology as measured by heart rate variability. Reduced heart rate variability has been shown to be associated with depression, and such a physiological measure may allow for the detection of more subtle effects than would a self-report questionnaire alone. Healthy volunteers (N=60) will first complete the BDI and provide baseline measures of heart rate variability. Then they will attend two laboratory sessions, at which they will receive placebo or 0.2mg buprenorphine. The investigators have tested these low doses of buprenorphine in previous studies, and they produce measurable changes in mood and behavior in healthy volunteers. The investigators will collect measures of mood and physiological drug response (pupillometry, heart rate, and blood pressure) at regular intervals throughout each session, and will then examine their baseline indices of depressive symptomatology in relation to responses to the drug. The central hypothesis is that individuals with greater self-reported depressive symptoms and lower heart rate variability will experience the greatest enhancement of mood in response to buprenorphine. It is expected that this work will provide a better understanding of which individuals are most likely to experience positive mood effects in response to opioid drugs, and may therefore be at-risk for developing an opioid use disorder. Furthermore, it may lay the foundation for future research in the development of novel opioid-based treatments for depression.
Design: The study will use a 3-session within-subjects double-blind design in which participants will receive single doses of buprenorphine (0, 0.2 mg sublingual) in randomized order. All screening, orientation, and study session procedures will take place in the Human Behavioral Pharmacology Laboratory suite in the L4 wing of 5841 S. Maryland Ave.
Drug and Doses: Investigators will administer placebo, 0.2 mg buprenorphine (Temgesic) via sublingual tablet in counterbalanced order under double-blind conditions. These tablets dissolve within 5-8 minutes. This drug has been approved for treatment of severe pain. The onset of action after sublingual administration is 30 minutes, with a peak plasma concentration at 1/5-2 hours and a half-life of 5 hours. The dose of buprenorphine are very low, and the average maintenance dose for opioid abusers is 8 mg. Doses will be separated by at least 72 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose buprenorphine | Active comparator | Drug: 0.2mg BuprenorphineSubjects all receive placebo, 0.2 mg buprenorphine in crossover design |
| Placebo | Placebo comparator | Drug: PlaceboSubjects all receive placebo, 0.2 mg buprenorphine in crossover design |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers
- High school education
- Fluency in English
- BMI between 19 and 30
Key exclusion criteria (6 listed)
- Medical conditions contraindicating study participation
- Regularly medication use
- Current or past opioid abuse or dependence
- Current or past drug or alcohol dependence
- Psychiatric illness
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 |
|---|---|---|
| 0.2mg BuprenorphineSublingual buprenorphine tablets (0.2mg) | Drug | Low dose buprenorphine |
| PlaceboPlacebo | Drug | Placebo |
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 Response With and Without Buprenorphine
Time frame: 0 through 3 hours after dosing.
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25178815Falcon E, Maier K, Robinson SA, Hill-Smith TE, Lucki I. Effects of buprenorphine on behavioral tests for antidepressant and anxiolytic drugs in mice. Psychopharmacology (Berl). 2015 Mar;232(5):907-15. doi: 10.1007/s00213-014-3723-y. Epub 2014 Sep 3.
- Background: PubMed 16298066Sullivan MD, Edlund MJ, Steffick D, Unutzer J. Regular use of prescribed opioids: association with common psychiatric disorders. Pain. 2005 Dec 15;119(1-3):95-103. doi: 10.1016/j.pain.2005.09.020. Epub 2005 Nov 17.
- Background: PubMed 25191915Karp JF, Butters MA, Begley AE, Miller MD, Lenze EJ, Blumberger DM, Mulsant BH, Reynolds CF 3rd. Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults. J Clin Psychiatry. 2014 Aug;75(8):e785-93. doi: 10.4088/JCP.13m08725.
- Background: PubMed 18794671Nyhuis PW, Gastpar M, Scherbaum N. Opiate treatment in depression refractory to antidepressants and electroconvulsive therapy. J Clin Psychopharmacol. 2008 Oct;28(5):593-5. doi: 10.1097/JCP.0b013e31818638a4. No abstract available.
- Background: PubMed 7714228Bodkin JA, Zornberg GL, Lukas SE, Cole JO. Buprenorphine treatment of refractory depression. J Clin Psychopharmacol. 1995 Feb;15(1):49-57. doi: 10.1097/00004714-199502000-00008.
- Background: PubMed 25084802Striebel JM, Kalapatapu RK. The anti-suicidal potential of buprenorphine: a case report. Int J Psychiatry Med. 2014;47(2):169-74. doi: 10.2190/PM.47.2.g.
- Background: PubMed 19047522Licht CM, de Geus EJ, Zitman FG, Hoogendijk WJ, van Dyck R, Penninx BW. Association between major depressive disorder and heart rate variability in the Netherlands Study of Depression and Anxiety (NESDA). Arch Gen Psychiatry. 2008 Dec;65(12):1358-67. doi: 10.1001/archpsyc.65.12.1358.
- Background: PubMed 22651957Ipser JC, Terburg D, Syal S, Phillips N, Solms M, Panksepp J, Malcolm-Smith S, Thomas K, Stein DJ, van Honk J. Reduced fear-recognition sensitivity following acute buprenorphine administration in healthy volunteers. Psychoneuroendocrinology. 2013 Jan;38(1):166-70. doi: 10.1016/j.psyneuen.2012.05.002. Epub 2012 May 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.2mg Buprenorphine in people with Depression, 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 29 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 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 Response With and Without Buprenorphine (time frame: 0 through 3 hours after dosing.). 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 NCT02659787, which also lists 8 linked publications.
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 29 May 2019.