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Alcohol Use DisorderPhase 2NCT00360594

Acamprosate Initiated During Alcohol Detoxification

A Phase 2 study testing Acamprosate in people with Alcohol Use Disorder, run by Forest Laboratories at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Acamprosate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2006to Nov 2007
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females from the ages of 18 to 70 years old. Subjects over the age of 70 years old will be included at the discretion of the PI, with the expectation that these subjects should comprise of no more than 5% of the subjects.
  • Diagnosis of current alcohol dependence according to DSM-IV criteria [DSM-IV criteria will be determined by utilizing the Mini International Neuropsychiatric Interview (MINI)].
  • If necessary, can be medically detoxified in the outpatient setting, as determined by a medical clinician.
  • Meets the following drinking criteria, measured by TLFB: a. reports a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting pharmacotherapy, b. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) within 30 days of starting pharmacotherapy treatment and c. has had a drink within 48 hours of the intake/screening visit or has a CIWA score equal to or greater than 3.
  • Speaks, understands and prints in English.
  • Gives written informed consent.

Who cannot join

  • Subjects mandated to treatment based upon a legal decision or as a condition of employment.
  • Subjects with evidence of substance dependence other than alcohol or nicotine dependence.
  • Subjects with psychosis or dementia at the time of the initial evaluation.
  • Female Subjects who are pregnant or lactating, or female Subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include: tubal ligation, barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, and oral contraceptives.
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG first degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <5 x ULN are acceptable), Subjects with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
  • Subjects who have a positive urine drug screening (cocaine, amphetamines, opiates, barbiturates, benzodiazepines)
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  • Subjects who have any disease of the gastrointestinal tract, liver or kidneys that could result in a possibility of altered metabolism or excretion of the study drug. As it is not possible to enumerate the many conditions which might impair absorption, metabolism, or excretion, the investigators will be guided by evidence such as: History of major gastrointestinal tract surgery (gastrectomy, gastrostomy, bowel resection, etc.) or a history of an active peptic ulcer or chronic disease of the GI tract, (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).
  • Current unstable heart disease.
  • Known hypersensitivity to acamprosate.
  • Subjects taking psychotropic drugs (e.g., antidepressants, anxiolytic, antipsychotic, naltrexone, disulfiram, modafinil, stimulants and anticonvulsants) with the exception of oxazepam
  • Subjects receiving formal psychotherapy
  • Subjects having participated in any investigational drug trial within 30 days prior to the study.
  • Subjects with AIDS or other serious illnesses that may require hospitalization during the study.
  • Inclusion Criteria for Post-Detoxification Rehabilitative Treatment Phase (RP/Phase 2) with Open-Label Acamprosate
  • Has taken at least 5 days of acamprosate or placebo directly prior to initiating open-label acamprosate.
  • Successfully completed, within a 14-day period, outpatient detoxification. Successful completion of detoxification is defined as having a score of 1 or lower on the Clinical Institutes Withdrawal Assessment for Alcohol (CIWA; Shaw et al., 1981), and has at least 3 consecutive days of abstinence.
  • Has reduced medication taken specifically for detoxification (if applicable), i.e., oxazepam to 45 mg within 24-hour period prior to the post-detoxification rehabilitative treatment phase.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Treatment Research Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Initiating Acamprosate Within Versus Post-detoxification in the Rehabilitative Treatment of Alcohol Dependence.

Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with acamprosate.

Read the detailed description

Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment phase (RP).

Being tested
Acamprosate, Placebo
Keywords
alcoholism
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcamprosateDrug

    Also called Campral

    3 pills (666 mg) for 1998mg/day

  • PlaceboDrug

    3 pills (666mg) for 1998mg/day

Study groups in NCT00360594
Study groupRoleWhat they receive
1ExperimentalAcamprosate
Receives: Drug: Acamprosate
2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1) the mean number of adverse events rated moderate to severe;

    Measured: Phase I: up to 2 weeks

  2. 2) the week of detoxification treatment discontinuation;

    Measured: Phase I: up to 2 weeks

  3. 3) the total amount of oxazepam given;

    Measured: Phase I: up to 2 weeks

  4. 4) the rate of change in CIWA scores.

    Measured: Phase I: up to 2 weeks

  5. 1) the mean number of adverse events rated moderate to severe;

    Measured: Phase II: 10 weeks

  6. 2) the week of open-label treatment discontinuation;

    Measured: Phase II: 10 weeks

  7. 3) any reemergence of detoxification symptoms;

    Measured: Phase II: 10 weeks

  8. 4) % pills taken over what was proposed to be prescribed (medication exposure);

    Measured: Phase II: 10 weeks

  9. 5) % days abstinent;

    Measured: Phase II: 10 weeks

  10. 6) % days heavy drinking.

    Measured: Phase II: 10 weeks

Secondary outcomes (6)

  1. Changes in alcohol craving will be measured by Penn Alcohol Craving Scale (PACS; Flannery et al, 1999)

    Measured: 12 weeks

  2. Changes in anxiety symptoms will be measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A; Hamilton, 1969)

    Measured: 12 weeks

  3. Changes in depressive symptoms will be measured by the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D; Hamilton 1967)

    Measured: 12 weeks

  4. Changes in social functioning will be measured by several of the subscales of the Addiction Severity Index (ASI; McLellan et al, 1992); namely, medical, legal, psychiatric, and family/social.

    Measured: 12 weeks

  5. Quality of Life, measured by the Short Form-36 Health Status Questionnaire (SF-36; Ware & Sherbourne, 1999)

    Measured: 12 weeks

  6. Overall clinical impression of improvement will be measured by the Clinical Global Impression Scale (CGI)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2007
  4. Study completionNov 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360594
Sponsor's protocol ID
804481
Other IDs
P50DA012756-07, CMP-MD-08, DPMC
Status last verified
Jun 2010
First submitted
2 Aug 2006
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Kampman KM, Pettinati HM, Lynch KG, Xie H, Dackis C, Oslin DW, Sparkman T, Sharkoski T, O'Brien CP. Initiating acamprosate within-detoxification versus post-detoxification in the treatment of alcohol dependence. Addict Behav. 2009 Jun-Jul;34(6-7):581-6. doi: 10.1016/j.addbeh.2009.03.014. Epub 2009 Mar 24.

    PubMed 19345510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acamprosate in people with Alcohol Use Disorder, run by Forest Laboratories 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 17 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 11 Jan 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

1) the mean number of adverse events rated moderate to severe; (time frame: Phase I: up to 2 weeks). The study lists 10 primary outcomes in all. 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 NCT00360594, which also lists 1 linked publication.

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 11 Jan 2017.

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