Anorexia NervosaPhase 3NCT00760695
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
A Phase 3 study testing dronabinol in people with Anorexia Nervosa, run by Odense University Hospital at 1 site in Denmark.
Trial summary
A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist. Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo Secondary end points: Motor and inner restlessness and hormonal changes during the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under treatment for AN.
- Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
- Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.
- Age over 18.
- Duration of the disease over 5 years.
Who cannot join
- Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
- Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
- Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
- Patients not attending to the weekly controls.
- If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
- Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
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- Patients with known allergy to dronabinol or sesame oil.
- Fertile, menstruating women not using safe contraception.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.
Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo
Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.
Read the detailed description
The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on:
- Weight
- Eating Disorder Inventory (EDI) scale
- Motor and inner restlessness (estimated by accelerometry)
- Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.
- Conditions
- Anorexia Nervosa
- Being tested
- dronabinol, placebo
- Keywords
- anorexia nervosa, chronic, dronabinol, weight gain, EDI
- Medical subject headings
- Anorexia Nervosa, Bronchiolitis Obliterans Syndrome, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronabinolDrug
Also called Marinol
tablets, twice daily, for 4 weeks
placeboDrug
tablets, twice daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | the patients in this arm are receiving 2,5 mg dronabinol twice daily Receives: Drug: dronabinol |
| B | Placebo comparator | the patients in this arm are receiving 2,5 mg placebo twice daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 4 weeks
Secondary outcomes (3)
Eating Disorder Inventory (EDI) scale
Measured: 4 weeks
Motor and inner restlessness (estimated by accelerometry)
Measured: 4 weeks
Endocrine parameters
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tine Hylle, Odense University Hospital
- Investigators
- Andries Alin, physician, Principal investigator, Endocrinological Department, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760695
- Sponsor's protocol ID
- 033
- Status last verified
- May 2013
- First submitted
- 25 Sep 2008
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00760695
- Acronym / sponsor ID
- 033
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, chronic, dronabinol, weight gain, EDI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Sep 2008 (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.
A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.
Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo
Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.
Detailed description
The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on:
- Weight
- Eating Disorder Inventory (EDI) scale
- Motor and inner restlessness (estimated by accelerometry)
- Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: dronabinolthe patients in this arm are receiving 2,5 mg dronabinol twice daily |
| B | Placebo comparator | Drug: placebothe patients in this arm are receiving 2,5 mg placebo twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients under treatment for AN.
- Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
- Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.
- Age over 18.
- Duration of the disease over 5 years.
Key exclusion criteria (9 listed)
- Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
- Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
- Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
- Patients not attending to the weekly controls.
- If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
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 |
|---|---|---|
| dronabinolAlso: Marinoltablets, twice daily, for 4 weeks | Drug | A |
| placebotablets, twice daily, for 4 weeks | Drug | B |
Primary outcome
Weight gain
Time frame: 4 weeks
3 secondary outcomes
Eating Disorder Inventory (EDI) scale
Time frame: 4 weeks
Motor and inner restlessness (estimated by accelerometry)
Time frame: 4 weeks
Endocrine parameters
Time frame: 4 weeks
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 10 May 2013.
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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.
Andries Alin, physician principal investigator
Endocrinological Department, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dronabinol in people with Anorexia Nervosa, run by Odense University Hospital at 1 site in Denmark.
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 5 inclusion and 9 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 10 May 2013. 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 Denmark. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Weight gain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2013.