Alcohol CravingPhase 3CAR-Bern 2013NCT02196142
Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence
A Phase 3 study testing Cortisol 20mg in people with Alcohol Craving and Psychological Stress, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects. Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Craving, Psychological Stress, Physiological Stress
- What is being tested?
- Cortisol 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jun 2015
- 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
- Age ≥ 18
- Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang
- Abstained from alcohol for at least 6 weeks
- Voluntarily signed informed consent
Who cannot join
- Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)
- Current medical conditions excluding participation (such as acute infectious disease)
- Recent history of systemic or topic glucocorticoid therapy
- Known hypersensitivity to the IMP under investigation (cortisol)
- Pregnancy, breast-feeding
- Inability to read and understand the participant's information
- Positive alcohol test according to breathalyser
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects.
Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication.
Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.
Read the detailed description
Background
Alcohol dependence is a chronically and relapsing disorder with major impact on the persons psychological, physiological and social functioning. There is extensive evidence from animal and human studies pointing out the important role of addiction memory in the development and maintenance of the disorder.
Cognitive behavioural therapy (CBT) has proven its high effectiveness in the treatment for addictive disorders. A core element of CBT are exposure techniques that are comparable to extinction and habituation learning. The repeated exposure to alcohol related cues in the absence of alcohol ingestion will lead to extinction of conditioned responses, thus reducing the probability of relapse to alcohol taking behaviour.
Studies have shown that glucocorticoids impair memory retrieval in healthy subjects. In fact, the investigators could show that cortisol has a fear reducing effect in patients with post-traumatic stress disorder and in phobic patients, resulting particularly in reduced symptoms of anxiety and in reduced stress reactivity. Interestingly enough, pharmacologically induced high levels of glucocorticoids lowered the subjective feeling of anxiety and stress in situations activating per se the HPA-axis. Further it has been shown that the combined therapy of glucocorticoid administration and exposition based psychotherapy leads to better therapy outcome in patients with specific phobias.
Objective
The goal of this study is to examine the acute effects of glucocorticoids administration on alcohol craving and stress reactivity of abstinent alcohol dependent patients. On the basis of clinical research in anxiety disorders, the investigators expect that a pharmacologically increased cortisol level may impair the retrieval of addiction memory, which is indicated by less craving during the alcohol exposition, while exposition therapy enhances consolidation of corrective experiences. Similar to the research in anxiety patients, the investigators aim to examine whether cortisol administration could help improve the effects of exposition therapy in patients with alcohol dependence. The purpose is to decrease therapy duration through cortisol administration in addition to already well proven therapies and make the therapy more efficient as well as a factor in reducing healthcare costs.
Methods
Patients undergo two identical experimental sessions between the 6th and 8th week (one week in between) of their 12-week inpatient treatment program for alcohol dependence. The experiment takes place in the experimental rooms of the clinic Südhang between 1 and 6 pm. One hour before the confrontation with alcohol associated stimuli patients receive either 20mg of hydrocortisone or placebo (oral administration). The experiment consists of a computer based picture task (alcoholic and neutral pictures) and an in-vivo exposure task. Psychological (craving, stress, arousal) and physiological (heart rate, saliva cortisol) parameters are repeatedly measured over the course of the experiment.
- Conditions
- Alcohol Craving, Psychological Stress, Physiological Stress
- Being tested
- Cortisol 20mg, Placebo Mannitol
- Keywords
- Cortisol, Alcohol Craving, Alcohol Dependence
- Medical subject headings
- Stress, Psychological, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortisol 20mgDrug
Drug: Cortisol 20mg
Placebo MannitolDrug
Drug: Placebo Mannitol
| Study group | Role | What they receive |
|---|---|---|
| Cortisol first, Placebo second | Active comparator | Drug: Cortisol 20mg, Drug: Mannitol (used as placebo) Receives: Drug: Cortisol 20mg; Drug: Placebo Mannitol |
| Placebo first, Cortisol second | Active comparator | Drug: Cortisol 20mg, Drug: Mannitol (used as placebo) Receives: Drug: Cortisol 20mg; Drug: Placebo Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in alcohol craving score
Measured by Alcohol Urge Questionnaire \& Visual Analogue Scale
Measured: During and after presentation of drug stimuli, expected to be after 10 minutes
Secondary outcomes (3)
Change from baseline in State-Trait-Anger Expression Inventory STAXI
Measured: After presentation of drug stimuli, expected to be after 20 minutes
Change from baseline in heart rate variability
Measured: During and after presentation of drug stimuli, expected to be after 10 minutes
Saliva Cortisol Level
Measured: After presentation of drug stimuli, expected to be after 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol CravingStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila Soravia, Dr. phil., Study director, University Hospital of Psychiatry BernPeter Allemann, Dr. med., Principal investigator, Clinic SüdhangDominique de Quervain, Prof. Dr., Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196142
- Sponsor's protocol ID
- 068/14
- Acronym
- CAR-Bern 2013
- Status last verified
- Jun 2015
- First submitted
- 17 Jul 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02196142
- Acronym / sponsor ID
- CAR-Bern 2013 / 068/14
- Conditions
- Alcohol Craving, Psychological Stress, Physiological Stress
- Keywords
- Cortisol, Alcohol Craving, Alcohol Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Jul 2014 (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.
To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects.
Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication.
Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.
Detailed description
Background
Alcohol dependence is a chronically and relapsing disorder with major impact on the persons psychological, physiological and social functioning. There is extensive evidence from animal and human studies pointing out the important role of addiction memory in the development and maintenance of the disorder.
Cognitive behavioural therapy (CBT) has proven its high effectiveness in the treatment for addictive disorders. A core element of CBT are exposure techniques that are comparable to extinction and habituation learning. The repeated exposure to alcohol related cues in the absence of alcohol ingestion will lead to extinction of conditioned responses, thus reducing the probability of relapse to alcohol taking behaviour.
Studies have shown that glucocorticoids impair memory retrieval in healthy subjects. In fact, the investigators could show that cortisol has a fear reducing effect in patients with post-traumatic stress disorder and in phobic patients, resulting particularly in reduced symptoms of anxiety and in reduced stress reactivity. Interestingly enough, pharmacologically induced high levels of glucocorticoids lowered the subjective feeling of anxiety and stress in situations activating per se the HPA-axis. Further it has been shown that the combined therapy of glucocorticoid administration and exposition based psychotherapy leads to better therapy outcome in patients with specific phobias.
Objective
The goal of this study is to examine the acute effects of glucocorticoids administration on alcohol craving and stress reactivity of abstinent alcohol dependent patients. On the basis of clinical research in anxiety disorders, the investigators expect that a pharmacologically increased cortisol level may impair the retrieval of addiction memory, which is indicated by less craving during the alcohol exposition, while exposition therapy enhances consolidation of corrective experiences. Similar to the research in anxiety patients, the investigators aim to examine whether cortisol administration could help improve the effects of exposition therapy in patients with alcohol dependence. The purpose is to decrease therapy duration through cortisol administration in addition to already well proven therapies and make the therapy more efficient as well as a factor in reducing healthcare costs.
Methods
Patients undergo two identical experimental sessions between the 6th and 8th week (one week in between) of their 12-week inpatient treatment program for alcohol dependence. The experiment takes place in the experimental rooms of the clinic Südhang between 1 and 6 pm. One hour before the confrontation with alcohol associated stimuli patients receive either 20mg of hydrocortisone or placebo (oral administration). The experiment consists of a computer based picture task (alcoholic and neutral pictures) and an in-vivo exposure task. Psychological (craving, stress, arousal) and physiological (heart rate, saliva cortisol) parameters are repeatedly measured over the course of the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortisol first, Placebo second | Active comparator | Drug: Cortisol 20mg, Drug: Placebo MannitolDrug: Cortisol 20mg, Drug: Mannitol (used as placebo) |
| Placebo first, Cortisol second | Active comparator | Drug: Cortisol 20mg, Drug: Placebo MannitolDrug: Cortisol 20mg, Drug: Mannitol (used as placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang
- Abstained from alcohol for at least 6 weeks
- Voluntarily signed informed consent
Key exclusion criteria (7 listed)
- Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)
- Current medical conditions excluding participation (such as acute infectious disease)
- Recent history of systemic or topic glucocorticoid therapy
- Known hypersensitivity to the IMP under investigation (cortisol)
- Pregnancy, breast-feeding
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 |
|---|---|---|
| Cortisol 20mgDrug: Cortisol 20mg | Drug | Cortisol first, Placebo second, Placebo first, Cortisol second |
| Placebo MannitolDrug: Placebo Mannitol | Drug | Cortisol first, Placebo second, Placebo first, Cortisol second |
Primary outcome
Change from baseline in alcohol craving score
Time frame: During and after presentation of drug stimuli, expected to be after 10 minutes
Measured by Alcohol Urge Questionnaire \& Visual Analogue Scale
3 secondary outcomes
Change from baseline in State-Trait-Anger Expression Inventory STAXI
Time frame: After presentation of drug stimuli, expected to be after 20 minutes
Change from baseline in heart rate variability
Time frame: During and after presentation of drug stimuli, expected to be after 10 minutes
Saliva Cortisol Level
Time frame: After presentation of drug stimuli, expected to be after 90 minutes
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 24 Jun 2015.
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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.
Leila Soravia, Dr. phil. study director
University Hospital of Psychiatry Bern
Peter Allemann, Dr. med. principal investigator
Clinic Südhang
Dominique de Quervain, Prof. Dr. study chair
University Hospital, Basel, Switzerland
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 Cortisol 20mg in people with Alcohol Craving and Psychological Stress, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 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 24 Jun 2015. 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 Switzerland. 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?
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?
Change from baseline in alcohol craving score (time frame: During and after presentation of drug stimuli, expected to be after 10 minutes). 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 24 Jun 2015.