Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, FollowedEarly Phase 1NCT01656577
Pexacerfont for Stress-induced Food Craving
A Early Phase 1 study testing Pexacerfont in people with Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed and Placebo, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed, Placebo
- What is being tested?
- Pexacerfont
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2015
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) > 22 kg/m(2)
- Score of 15 or higher on the Dietary Restraint Scale, with endorsement of the Restraint
- Scale item Do you give too much time and thought to food?
- Age 21 - 65 years.
- (4a) For women of childbearing potential: must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug, and agree to use an adequate method of contraception to avoid pregnancy for a period of 6 months beginning from first dose of randomized treatment. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progesterone only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap; or using an approved intrauterine device (IUD) with established efficacy.
- (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment.
Who cannot join
- Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device.
- Participation in a clinical study for a condition related to weight or dieting within the preceding month.
- Any history of participation in a trial involving pexacerfont or closely related compounds.
- Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples include but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack.
- For women: pregnancy, breastfeeding, or planning to become pregnant within 6 months from the administration of first dose of study drug.
Show all 33Show fewer
- Past or present diagnosis of any eating disorder, including Anorexia Nervosa, Bulimia Nervosa, and Eating Disorder NOS (e.g., Binge-Eating Disorder). (Eating-disordered individuals probably represent a distinct population and should therefore be studied separately.)
- Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder; past or present diagnosis of dementia or any other disorder that has led to a clinically significant cognitive impairment; present diagnosis of any mood or anxiety disorder; any other psychiatric condition that presently requires, or in the past month has required, pharmacological intervention.
- Past or present diagnosis of any substance-use disorder except nicotine dependence.
- Urine tests positive for illegal drugs.
- Evidence of thyroid disorder by medical history or screening physical exam, with TSH < 0.36 or greater than 3.74 UIU/ml; or current or history of use of thyroid medication.
- Adrenal or pituitary pathology as evidenced by medical history or suggested by abnormal screening labs.
- Current seizure disorder or a significant history (as judged by the investigators) of a seizure disorder, other significant neurological disorders (e.g., Parkinson's Disease, multiple sclerosis, stroke, neurodegenerative disease, cerebral palsy) or severe head trauma (including closed head trauma, penetrating head injury, skull fracture, or intracranial hemorrhage), or CNS tumor.
- Active liver disease or a history of hepatic intolerance to medications that, in the investigators' judgment, is medically significant.
- History of diabetes mellitus type I and II or gastric bypass or reduction surgery.
- Justification: illnesses that change metabolism or the absorption from the GI tract, would interfere with drug metabolism or absorption).
- Difficulty swallowing tablets or capsules.
- Exclusionary physical and laboratory test findings:
- QTc > 475 msec
- platelets less than or equal to 75,000/mm(3)
- hemoglobin less than or equal to 9g/dL
- neutrophils, absolute less than or equal to 1000/mm3
- SGOT (AST) > 2.5 times upper limit of normal
- SGPT (ALT) > 2.5 times upper limit of normal
- bilirubin 2 times upper limit of normal
- GFR < 60mL/min/1.73m2 or significant proteinuria
- diastolic blood pressure > 105 mmHg
- TSH < 0.36 or > 3.74 UIU/ml
- Current use or history of use in the last 3 months of psychiatric medications, including but not limited to antidepressants, lithium, antipsychotics, anxiolytics, antiepileptics, opiates, or hypnotics.
- Any change in a non-excluded medication in the past 3 months.
- Systemic intake of corticosteroids acutely within 2 weeks or chronically (> 28 days) within the last 6 months. (Topical hydrocortisone and inhaled corticosteroids are allowed.)
- Use of medications that are CYP3A4 inhibitors or inducers (see Appendix 3); study applicants should not take these medications for at least 7 days prior to randomization and during the remainder of the study.
- Dietary restrictions or food aversions that would interfere with valid assessment of eating in our laboratory sessions.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pexacerfont for Reduction of Stress-Induced Food Craving and Eating in Humans
Background:
- Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings.
Read more
Objectives:
- To see if pexacerfont can help reduce stress-induced food cravings.
Eligibility:
- Individuals between 21 and 65 years of age who are on a diet to control their weight.
Design:
- Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days.
- Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day.
- Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving.
- Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits.
- Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.
Read the detailed description
Objective: To evaluate pexacerfont, an orally available, brain-penetrant selective CRF1 antagonist, for its ability to modulate food craving and consumption in chronic unsuccessful dieters.
Study population: We will collect evaluable data from up to 90 restrained eaters (individuals who indicate a history of chronic yo-yo dieting by scoring 15 or higher on the Dietary Restraint Scale). To ensure that all participants have some degree of preoccupation with food, an additional inclusion criterion will be endorsement of the Restraint Scale item Do you give too much time and thought to food? Apart from their preoccupation with food, participants will be healthy. They can be either normal-weight or overweight (Body Mass Index (BMI) > 22kg/m2); this will be stratified across dose groups.
Frank eating disorders will be exclusionary.
Design: This will be a randomized, double-blind, between-groups study with two groups.
Participants will be stabilized on either pexacerfont or placebo for 28 days (300 mg/day loading dose for 7 days, followed by 100 mg/day maintenance dose for 21 days). On day 15, they will undergo a math-test stressor and have stress-induced food consumption and craving assessed in a bogus taste test and on visual-analog scales. During three subsequent visits between days 16 and 28, they will be exposed to three personalized imagery-induction scripts-one stress-related, one food-related, and one neutral/relaxing. Food craving and food consumption will be assessed on those visits as well.
Outcome measures: The primary outcome measure is stress-induced eating after the math-test stressor. Other outcome measures will include spontaneous food consumption after the other stressors, subjective ratings of stress, mood, and food craving, autonomic responses (galvanic skin response (GSR), heart rate, and blood pressure), and endocrine responses (salivary cortisol, salivary alpha-amylase, and serum cortisol).
- Being tested
- Pexacerfont
- Keywords
- CRF1 antagonist, Stress, Eating Behavior, Food Craving
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PexacerfontDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, FollowedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David H Epstein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656577
- Sponsor's protocol ID
- 999912475
- Other IDs
- 12-DA-N475
- Status last verified
- Jun 2012
- First submitted
- 31 Jul 2012
- Last updated
- 18 Aug 2016
- Results posted
- No
Publications
Avena NM, Rada P, Hoebel BG. Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neurosci Biobehav Rev. 2008;32(1):20-39. doi: 10.1016/j.neubiorev.2007.04.019. Epub 2007 May 18.
PubMed 17617461Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008 May;165(5):617-20. doi: 10.1176/appi.ajp.2008.07071199. Epub 2008 Apr 15.
PubMed 18413705Cottone P, Sabino V, Roberto M, Bajo M, Pockros L, Frihauf JB, Fekete EM, Steardo L, Rice KC, Grigoriadis DE, Conti B, Koob GF, Zorrilla EP. CRF system recruitment mediates dark side of compulsive eating. Proc Natl Acad Sci U S A. 2009 Nov 24;106(47):20016-20. doi: 10.1073/pnas.0908789106. Epub 2009 Nov 9.
PubMed 19901333Epstein DH, Kennedy AP, Furnari M, Heilig M, Shaham Y, Phillips KA, Preston KL. Effect of the CRF1-receptor antagonist pexacerfont on stress-induced eating and food craving. Psychopharmacology (Berl). 2016 Dec;233(23-24):3921-3932. doi: 10.1007/s00213-016-4424-5. Epub 2016 Sep 5.
PubMed 27595147
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pexacerfont for Reduction of Stress-Induced Food Craving and Eating in Humans
- ClinicalTrials.gov ID
- NCT01656577
- Acronym / sponsor ID
- 999912475
- Keywords
- CRF1 antagonist, Stress, Eating Behavior, Food Craving
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Aug 2012 (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.
Background:
- Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings.
Objectives:
- To see if pexacerfont can help reduce stress-induced food cravings.
Eligibility:
- Individuals between 21 and 65 years of age who are on a diet to control their weight.
Design:
- Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days.
- Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day.
- Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving.
- Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits.
- Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.
Detailed description
Objective: To evaluate pexacerfont, an orally available, brain-penetrant selective CRF1 antagonist, for its ability to modulate food craving and consumption in chronic unsuccessful dieters.
Study population: We will collect evaluable data from up to 90 restrained eaters (individuals who indicate a history of chronic yo-yo dieting by scoring 15 or higher on the Dietary Restraint Scale). To ensure that all participants have some degree of preoccupation with food, an additional inclusion criterion will be endorsement of the Restraint Scale item Do you give too much time and thought to food? Apart from their preoccupation with food, participants will be healthy. They can be either normal-weight or overweight (Body Mass Index (BMI) > 22kg/m2); this will be stratified across dose groups.
Frank eating disorders will be exclusionary.
Design: This will be a randomized, double-blind, between-groups study with two groups.
Participants will be stabilized on either pexacerfont or placebo for 28 days (300 mg/day loading dose for 7 days, followed by 100 mg/day maintenance dose for 21 days). On day 15, they will undergo a math-test stressor and have stress-induced food consumption and craving assessed in a bogus taste test and on visual-analog scales. During three subsequent visits between days 16 and 28, they will be exposed to three personalized imagery-induction scripts-one stress-related, one food-related, and one neutral/relaxing. Food craving and food consumption will be assessed on those visits as well.
Outcome measures: The primary outcome measure is stress-induced eating after the math-test stressor. Other outcome measures will include spontaneous food consumption after the other stressors, subjective ratings of stress, mood, and food craving, autonomic responses (galvanic skin response (GSR), heart rate, and blood pressure), and endocrine responses (salivary cortisol, salivary alpha-amylase, and serum cortisol).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scale item Do you give too much time and thought to food?
- (4a) For women of childbearing potential: must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug, and agree to use an adequate method of contraception to avoid pregnancy for a period of 6 months beginning from first dose of randomized treatment. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progesterone only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap; or using an approved intrauterine device (IUD) with established efficacy.
- (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment.
Key exclusion criteria (33 listed)
- Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device.
- Participation in a clinical study for a condition related to weight or dieting within the preceding month.
- Any history of participation in a trial involving pexacerfont or closely related compounds.
- Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples include but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack.
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 |
|---|---|---|
| Pexacerfont | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Background: PubMed 17617461Avena NM, Rada P, Hoebel BG. Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neurosci Biobehav Rev. 2008;32(1):20-39. doi: 10.1016/j.neubiorev.2007.04.019. Epub 2007 May 18.
- Background: PubMed 18413705Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008 May;165(5):617-20. doi: 10.1176/appi.ajp.2008.07071199. Epub 2008 Apr 15.
- Background: PubMed 19901333Cottone P, Sabino V, Roberto M, Bajo M, Pockros L, Frihauf JB, Fekete EM, Steardo L, Rice KC, Grigoriadis DE, Conti B, Koob GF, Zorrilla EP. CRF system recruitment mediates dark side of compulsive eating. Proc Natl Acad Sci U S A. 2009 Nov 24;106(47):20016-20. doi: 10.1073/pnas.0908789106. Epub 2009 Nov 9.
- Derived from this study: PubMed 27595147Epstein DH, Kennedy AP, Furnari M, Heilig M, Shaham Y, Phillips KA, Preston KL. Effect of the CRF1-receptor antagonist pexacerfont on stress-induced eating and food craving. Psychopharmacology (Berl). 2016 Dec;233(23-24):3921-3932. doi: 10.1007/s00213-016-4424-5. Epub 2016 Sep 5.
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.
David H Epstein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Pexacerfont in people with Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed and Placebo, run by National Institute on Drug Abuse (NIDA) 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 6 inclusion and 33 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: stopped early, as of the sponsor's last update on 18 Aug 2016. 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. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656577, which also lists 4 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 18 Aug 2016.