Alcohol DependencePhase 4SAFADIENCT00655967
Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)
A Phase 4 study testing Acamprosate (Campral) and Acamprosate in people with Alcohol Dependence, run by University of New Mexico at 1 site in United States.
Trial summary
Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulfiram, naltrexone and acamprosate. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Acamprosate (Campral) and Acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2006
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, men and women, age 60 and older.
- Patients with Alcohol Dependence as determined by SCID I section for substance use disorders who are not in full sustained remission.
- Patients who have consumed significant amounts of alcohol in the past 30 days, as determined by Time Line Follow Back report by patient and patient's spouse, partner or friend. Significant amounts is defined for these purposes as at least one episode of 5 or more drinks, with a drink defined as one bottle of beer, one glass of wine or one shot of liquor.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients, who signed the written informed consent given prior to entering any study procedure and completed the informed consent quiz.
Who cannot join
- Patients with the following concurrent DSM-IV Axis I diagnoses as determined by the relevant sections of SCID I:
- Current, acute psychosis regardless of etiology
- Moderate to severe dementia regardless of etiology, defined as a MMSE score of 18 or less out of 30.
- Current opioid, cocaine or amphetamine dependence, defined as not meeting criteria for sustained full remission.
- Patients with significant or unstable medical conditions as determined by investigator. This is defined as a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety during the course of the trial.
- Patients with significantly abnormal lab values, as determined by the investigator, including creatinine clearance less than 30 as determined by Cockcroft-Gault estimate.
- Patients with a history of intolerance or hypersensitivity to acamprosate.
- Patients who are actively suicidal.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131-0001
About this study
Official title: Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study
Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique in that it is not metabolized by the liver, but rather completely excreted renally. In contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram (PDR 2005). The incidence of liver disease among alcoholics is high and increases with age and years of drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent patients with liver disease or that are elderly . Thus acamprosate has a unique safety profile that would make it ideally suited for treating alcohol dependence in the elderly, even in the presence of hepatic impairment. The current study is to evaluate the safety profile of acamprosate in elderly patients with alcohol dependence.
Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and the U.S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA) receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al. 2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003). There is limited data on the safety of acamprosate in the elderly (PDR 2005).
Read more
For the purposes of this study, elderly will be defined as 60 years or older.
STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of alcohol dependence in the elderly.
Read the detailed description
STUDY DESIGN: This trial will be conducted as an open-label, fixed dose design for safety of Acamprosate in the elderly. Subjects will receive Acamprosate for 12 weeks. The schedule of visits will include screening, baseline and three monthly follow-up visits at days 30, 60 and 90. We will recruit 25 subjects in the total study period of 15 month.
Regarding the number of subjects, chi-squared analysis of the total number of side effects (61%, i.e. 1230 out of 2018 subjects in prior studies) and the possible number of subjects in the study with side effects (from 0 to 25), indicates that a significant (alpha=0.05) difference from the previously observed rate would occur if less than 11 (p<=0.05) or more than 20 (p<=0.025) subjects report side effects. Side effects in 11 to 20 subjects would be nonsignificantly different from the previously published rates. Thus 25 subjects are sufficient to detect significant deviation in frequency of overall side effects in this sample compared to the subjects in prior studies. Total number of side effects was used for this calculation because there is no single common or significant side effect that would lend itself as an appropriate surrogate for the side effects overall.
During the course of the study subjects will be supplied with 333mg tablets of Acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for subjects with a creatinine clearance >50. The dose will be 333mg three times a day for subjects with a creatinine clearance in the range of 30-50.
Safety will be monitored by subject's report of adverse events at all treatment visits throughout both, open label and double blind phases of the Trial. The report of adverse events or new symptoms by the subject will be reviewed and summarized. This may also include any clinically significant changes in the vital signs (blood pressure and pulse readings, weight, temperature), physical examinations, laboratory evaluations (blood chemistry, hematology, urinalysis, EKG) and recording of concomitant treatment. A DSMB plan has been set up.
Treatment compliance will be monitored by counts of returned medication, and subjects are to be counseled if they do not adhere, or if they are thought to be at risk for not adhering to the medication regimen.
- Conditions
- Alcohol Dependence
- Being tested
- Acamprosate (Campral), Acamprosate
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acamprosate (Campral)Drug
Also called Acamprosate(Campral)
During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
Treatment compliance will be monitored by counts of returned medication. Records of all concomitant medications will be taken at each study visit as well as reports of adverse events (as shown above).
AcamprosateDrug
Also called Acamprosate(Campral)
During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Acamprosate(Campral) Receives: Drug: Acamprosate (Campral); Drug: Acamprosate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be safety.
Measured: Patients will receive acamprosate for 12 weeks.The schedule of visits will include screening, baseline and and three monthly follow-up visits at days 30, 60 and 90. We will recruit 25 subjects in the total study period of 12 month.
Secondary outcomes (1)
Changes in the quantity of alcohol consumed as determined by Time Line Follow Back assessment by patient and parallel historian will be determined.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Birkmayer, M.D., Principal investigator, University of New Mexico, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655967
- Sponsor's protocol ID
- HRRC# 06-318
- Other IDs
- CMP-MD-11
- Acronym
- SAFADIE
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2008
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study
- ClinicalTrials.gov ID
- NCT00655967
- Acronym / sponsor ID
- SAFADIE / HRRC# 06-318
- Conditions
- Alcohol Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Dec 2006 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Apr 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.
Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulfiram, naltrexone and acamprosate. Of these, acamprosate is unique in that it is not metabolized by the liver, but rather completely excreted renally. In contrast, naltrexone is metabolized by the CYP450 system of the liver and less than 2% is excreted unchanged and can cause liver damage (PDR 2005). Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram (PDR 2005). The incidence of liver disease among alcoholics is high and increases with age and years of drinking and this may preclude the use of antabuse or naltrexone to help alcohol dependent patients with liver disease or that are elderly . Thus acamprosate has a unique safety profile that would make it ideally suited for treating alcohol dependence in the elderly, even in the presence of hepatic impairment. The current study is to evaluate the safety profile of acamprosate in elderly patients with alcohol dependence.
Acamprosate, calcium acetyl homotaurinate, has been approved in most European countries and the U.S. for the maintenance of abstinence in recently detoxified alcoholics. The mechanism of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA) receptor tone in glutamatergic systems (Rammes et al 2001). Several trials of acamprosate confirm its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al. 2001; Slattery et al. 2003; Mann et al. 2004; Verheul et al. 2004). It also reduces the severity of relapse in alcoholics in abstinence based treatment programs (Chick et al. 2003). There is limited data on the safety of acamprosate in the elderly (PDR 2005).
For the purposes of this study, elderly will be defined as 60 years or older.
STUDY OBJECTIVE: To determine the short-term safety of Acamprosate in the treatment of alcohol dependence in the elderly.
Detailed description
STUDY DESIGN: This trial will be conducted as an open-label, fixed dose design for safety of Acamprosate in the elderly. Subjects will receive Acamprosate for 12 weeks. The schedule of visits will include screening, baseline and three monthly follow-up visits at days 30, 60 and 90. We will recruit 25 subjects in the total study period of 15 month.
Regarding the number of subjects, chi-squared analysis of the total number of side effects (61%, i.e. 1230 out of 2018 subjects in prior studies) and the possible number of subjects in the study with side effects (from 0 to 25), indicates that a significant (alpha=0.05) difference from the previously observed rate would occur if less than 11 (p<=0.05) or more than 20 (p<=0.025) subjects report side effects. Side effects in 11 to 20 subjects would be nonsignificantly different from the previously published rates. Thus 25 subjects are sufficient to detect significant deviation in frequency of overall side effects in this sample compared to the subjects in prior studies. Total number of side effects was used for this calculation because there is no single common or significant side effect that would lend itself as an appropriate surrogate for the side effects overall.
During the course of the study subjects will be supplied with 333mg tablets of Acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for subjects with a creatinine clearance >50. The dose will be 333mg three times a day for subjects with a creatinine clearance in the range of 30-50.
Safety will be monitored by subject's report of adverse events at all treatment visits throughout both, open label and double blind phases of the Trial. The report of adverse events or new symptoms by the subject will be reviewed and summarized. This may also include any clinically significant changes in the vital signs (blood pressure and pulse readings, weight, temperature), physical examinations, laboratory evaluations (blood chemistry, hematology, urinalysis, EKG) and recording of concomitant treatment. A DSMB plan has been set up.
Treatment compliance will be monitored by counts of returned medication, and subjects are to be counseled if they do not adhere, or if they are thought to be at risk for not adhering to the medication regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Acamprosate (Campral), Drug: AcamprosateAcamprosate(Campral) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients, men and women, age 60 and older.
- Patients with Alcohol Dependence as determined by SCID I section for substance use disorders who are not in full sustained remission.
- Patients who have consumed significant amounts of alcohol in the past 30 days, as determined by Time Line Follow Back report by patient and patient's spouse, partner or friend. Significant amounts is defined for these purposes as at least one episode of 5 or more drinks, with a drink defined as one bottle of beer, one glass of wine or one shot of liquor.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients, who signed the written informed consent given prior to entering any study procedure and completed the informed consent quiz.
Key exclusion criteria (8 listed)
- Patients with the following concurrent DSM-IV Axis I diagnoses as determined by the relevant sections of SCID I:
- Patients with significant or unstable medical conditions as determined by investigator. This is defined as a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety during the course of the trial.
- Patients with significantly abnormal lab values, as determined by the investigator, including creatinine clearance less than 30 as determined by Cockcroft-Gault estimate.
- Patients with a history of intolerance or hypersensitivity to acamprosate.
- Patients who are actively suicidal.
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 |
|---|---|---|
| Acamprosate (Campral)Also: Acamprosate(Campral)During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50. Treatment compliance will be monitored by counts of returned medication. Records of all concomitant medications will be taken at each study visit as well as reports of adverse events (as shown above). | Drug | 1 |
| AcamprosateAlso: Acamprosate(Campral)During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50. | Drug | 1 |
Primary outcome
The primary outcome will be safety.
Time frame: Patients will receive acamprosate for 12 weeks.The schedule of visits will include screening, baseline and and three monthly follow-up visits at days 30, 60 and 90. We will recruit 25 subjects in the total study period of 12 month.
1 secondary outcome
Changes in the quantity of alcohol consumed as determined by Time Line Follow Back assessment by patient and parallel historian will be determined.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
Florian Birkmayer, M.D. principal investigator
University of New Mexico, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acamprosate (Campral) and Acamprosate in people with Alcohol Dependence, run by University of New Mexico 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Aug 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
The primary outcome will be safety. (time frame: Patients will receive acamprosate for 12 weeks.The schedule of visits will include screening, baseline and and three monthly follow-up visits at days 30, 60 and 90. We will recruit 25 subjects in the total study period of 12 month.). 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 1 Aug 2023.