Food AddictionEarly Phase 1SHENCT01175512
Stress, Hormones, and Eating
A Early Phase 1 study testing Naltrexone in people with Food Addiction and How Opioid Tone Was Related to Self Reported, run by University of California, San Francisco.
Trial summary
The investigators will develop a measure of endogenous opioid tone that might serve as a biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators will assess whether individual response to one dose of an opioid receptor antagonist, naltrexone, is related to non-homeostatic eating… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Addiction, How Opioid Tone Was Related to Self Reported, Drive to Eat Using a Measure of Food Addiction
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Age > 20 to 45 years (pre-menopausal women)
- BMI > 30 and no larger than BMI = 40 or 300 pounds
Who cannot join
- Inability to provide informed consent or speak English
- Needle phobic or fainting in response to blood draw
- Diabetes
- Currently pregnant or breastfeeding
- Currently Smoke
- Bulimia (Binge Eating Disorder is common among the obese, and allowed)
Show all 16Show fewer
- Pacemaker
- Shift Worker
- Beta Blocker Medication use
- Liver Medication use
- Weight Loss Medication use
- Chronic current use of cortisol containing medications
- Kidney Disease (based on elevated Blood Urea Nitrogen and Creatinine)
- Illegal Drug Use (presence in urine)
- Liver Cirrhosis or Acute hepatitis (based on elevated Alanine transaminase)
- Substance abuse, mental health, or medical condition that, in the opinion of investigators, will affect study outcomes (e.g., hypertension, severe food allergies).
About this study
Official title: Novel Interventions to Reduce Stress Induced Non-homeostatic Eating
The investigators will develop a measure of endogenous opioid tone that might serve as a biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators will assess whether individual response to one dose of an opioid receptor antagonist, naltrexone, is related to non-homeostatic eating in non-pregnant women.
Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.
Read more
Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than the 50 mg dose. However, responses will be similarly related to non-homeostatic eating measures.
Hypothesis 3: Response to naltrexone will be highly stable within individuals across time, in the absence of an intervention.
Read the detailed description
Opioid tone may provide a way to identify people at risk of reward based eating, with more accuracy than self-report measures. Knowing such risk could improve treatment matching, and provide a biomarker to assess treatment progress. There is no direct measure of central opioid activity in humans, short of PET scans for opioid receptor binding. However, there is a promising indicator using an opioid antagonist such as naltrexone. Blocking opioid receptor releases the inhibitory opioidergic inputs to hypothalamic corticotropic releasing hormone (CRH) neurons, thus increasing CRH, and eventually cortisol in the blood. The extent of the cortisol rise in response to naltrexone might serve as an indicator of endogenous opioidergic tone. It is hypothesized that greater increases in cortisol indicate weaker endogenous opioid activity (by indicating a more complete opioid blockade). Salivary cortisol response to naltrexone may offer a relatively safe and unobtrusive way to measure endogenous opioidergic tone. We propose to test the reliability and validity of the naltrexone probe, taken at home, as a measure of endogenous opioidergic tone. In a previous study (Daubenmier et al, 2013), we administered a one time 50mg dose of naltrexone and examined nausea and cortisol responses. Results suggested that responses were higher in those who showed greater drive to eat. Here we examine a more direct measure of drive to eat, using the Yale Food Addiction Scale (YFAS), and test whether nausea and cortisol responses were associated with greater drive to eat, whether 50mg produced greater responses than 25 mg, and whether the responses were stable (highly related) when tested again one month later.
- Conditions
- Food Addiction, How Opioid Tone Was Related to Self Reported, Drive to Eat Using a Measure of Food Addiction
- Being tested
- Naltrexone, Placebo
- Keywords
- naltrexone, obesity, cortisol, food addiction
- Medical subject headings
- Food Addiction, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
PlaceboDrug
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | 4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | 4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ideal Dosage
- To examine criterion validity by testing whether level of opioid tone (based on response to naltrexone probe) is associated with self reported scores on non-homeostatic eating measures, behavioral and cognitive tasks assessing constructs related to addiction (eg, impulsivity) and ideal dosage (25 vs. 50 mg) in 60 obese women.
Measured: May 2012
Secondary outcomes (2)
Test Retest Reliability
- To examine test-retest reliability of naltrexone response one month later
Measured: May 2012
Home Based Measures Reliability
- To examine the reliability of home based measures. In other words, we will test whether cortisol and nausea responses taken in clinic, which are taken at highly controlled (accurate) times, are comparable to the responses from samples taken at home using saliva measures.
Measured: May 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Epel, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175512
- Sponsor's protocol ID
- 1U01HL097973-01
- Acronym
- SHE
- Status last verified
- Jan 2021
- First submitted
- 28 Jul 2010
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. Appetite. 2009 Apr;52(2):430-6. doi: 10.1016/j.appet.2008.12.003. Epub 2008 Dec 11.
PubMed 19121351Daubenmier J, Lustig RH, Hecht FM, Kristeller J, Woolley J, Adam T, Dallman M, Epel E. A new biomarker of hedonic eating? A preliminary investigation of cortisol and nausea responses to acute opioid blockade. Appetite. 2014 Mar;74:92-100. doi: 10.1016/j.appet.2013.11.014. Epub 2013 Nov 27.
PubMed 24291355
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Interventions to Reduce Stress Induced Non-homeostatic Eating
- ClinicalTrials.gov ID
- NCT01175512
- Acronym / sponsor ID
- SHE / 1U01HL097973-01
- Conditions
- Food Addiction, How Opioid Tone Was Related to Self Reported, Drive to Eat Using a Measure of Food Addiction
- Keywords
- naltrexone, obesity, cortisol, food addiction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will develop a measure of endogenous opioid tone that might serve as a biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators will assess whether individual response to one dose of an opioid receptor antagonist, naltrexone, is related to non-homeostatic eating in non-pregnant women.
Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.
Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than the 50 mg dose. However, responses will be similarly related to non-homeostatic eating measures.
Hypothesis 3: Response to naltrexone will be highly stable within individuals across time, in the absence of an intervention.
Detailed description
Opioid tone may provide a way to identify people at risk of reward based eating, with more accuracy than self-report measures. Knowing such risk could improve treatment matching, and provide a biomarker to assess treatment progress. There is no direct measure of central opioid activity in humans, short of PET scans for opioid receptor binding. However, there is a promising indicator using an opioid antagonist such as naltrexone. Blocking opioid receptor releases the inhibitory opioidergic inputs to hypothalamic corticotropic releasing hormone (CRH) neurons, thus increasing CRH, and eventually cortisol in the blood. The extent of the cortisol rise in response to naltrexone might serve as an indicator of endogenous opioidergic tone. It is hypothesized that greater increases in cortisol indicate weaker endogenous opioid activity (by indicating a more complete opioid blockade). Salivary cortisol response to naltrexone may offer a relatively safe and unobtrusive way to measure endogenous opioidergic tone. We propose to test the reliability and validity of the naltrexone probe, taken at home, as a measure of endogenous opioidergic tone. In a previous study (Daubenmier et al, 2013), we administered a one time 50mg dose of naltrexone and examined nausea and cortisol responses. Results suggested that responses were higher in those who showed greater drive to eat. Here we examine a more direct measure of drive to eat, using the Yale Food Addiction Scale (YFAS), and test whether nausea and cortisol responses were associated with greater drive to eat, whether 50mg produced greater responses than 25 mg, and whether the responses were stable (highly related) when tested again one month later.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: Naltrexone4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. |
| Placebo | Placebo comparator | Drug: Placebo4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women
- Age > 20 to 45 years (pre-menopausal women)
- BMI > 30 and no larger than BMI = 40 or 300 pounds
Key exclusion criteria (16 listed)
- Inability to provide informed consent or speak English
- Needle phobic or fainting in response to blood draw
- Diabetes
- Currently pregnant or breastfeeding
- Currently Smoke
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 |
|---|---|---|
| Naltrexone4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. | Drug | Naltrexone |
| Placebo4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo. | Drug | Placebo |
Primary outcome
Ideal Dosage
Time frame: May 2012
1) To examine criterion validity by testing whether level of opioid tone (based on response to naltrexone probe) is associated with self reported scores on non-homeostatic eating measures, behavioral and cognitive tasks assessing constructs related to addiction (eg, impulsivity) and ideal dosage (25 vs. 50 mg) in 60 obese women.
2 secondary outcomes
Test Retest Reliability
Time frame: May 2012
Home Based Measures Reliability
Time frame: May 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 19121351Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. Appetite. 2009 Apr;52(2):430-6. doi: 10.1016/j.appet.2008.12.003. Epub 2008 Dec 11.
- Background: PubMed 24291355Daubenmier J, Lustig RH, Hecht FM, Kristeller J, Woolley J, Adam T, Dallman M, Epel E. A new biomarker of hedonic eating? A preliminary investigation of cortisol and nausea responses to acute opioid blockade. Appetite. 2014 Mar;74:92-100. doi: 10.1016/j.appet.2013.11.014. Epub 2013 Nov 27.
- Study websiteLink provided by the sponsor.
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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.
Elissa Epel, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Naltrexone in people with Food Addiction and How Opioid Tone Was Related to Self Reported, run by University of California, San Francisco.
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 3 inclusion and 16 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ideal Dosage (time frame: May 2012). 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 NCT01175512, which also lists 2 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 28 Jan 2021.