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Alcohol DependencePhase 2NCT00981617

ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

A Phase 2 study testing ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg) and ALKS33 (RDC-0313) (10 mg) in people with Alcohol Dependence, run by Alkermes, Inc. at 27 sites 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

This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg) and ALKS33 (RDC-0313) (10 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
27 sitesUnited States
Study dates
Oct 2009to Aug 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women)
  • A noncustodial stable residence and a telephone
  • Women having reproductive potential must agree to use an approved method of contraception for the duration of the study
  • Ability to stop drinking prior to receiving study drug

Who cannot join

  • Pregnancy and/or current breastfeeding
  • Past or present history of an AIDS-indicator disease
  • Current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol)
  • Positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at Visits 1 and 2
  • Clinically significant medical condition
  • Current or anticipated need for prescribed opioid medication during the study period
Show all 10Show fewer
  • Use of naltrexone within 60 days prior to screening
  • Current need for antidepressants (within 30 days prior to entry)
  • Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
  • Parole or probation or pending legal proceedings that have the potential for incarceration during the study period

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Alkermes Investigational Site

    Albuquerque, New Mexico, 87102

  • Alkermes Investigational Site

    Atlanta, Georgia, 30320

  • Alkermes Investigational Site

    Atlanta, Georgia, 30328

  • Alkermes Investigational Site

    Brooklyn, New York, 11235

  • Alkermes Investigational Site

    Cerritos, California, 90703

  • Alkermes Investigational Site

    Charlotte, North Carolina, 28209

  • Alkermes Investigational Site

    Fall River, Massachusetts, 02720

  • Alkermes Investigational site

    Hickory, North Carolina, 28601

  • Alkermes Investigational Site

    Houston, Texas, 77090

  • Alkermes Investigational Site

    Jacksonville, Florida, 32216

  • Alkermes Investigational Site

    Lafayette, Indiana, 47905

  • Alkermes Investigational Site

    Las Vegas, Nevada, 89146

  • Alkermes Investigational Site

    Maitland, Florida, 32751

  • Alkermes Investigational Site

    Middleton, Wisconsin, 53562

  • Alkermes Investigational Site

    New Bern, North Carolina, 28562

  • Alkermes Investigational Site

    New York, New York, 10010

  • Alkermes Investigational Site

    Oceanside, California, 92056

  • Alkermes Investigational Site

    Oklahoma City, Oklahoma, 73103

  • Alkermes Investigational Site

    Orlando, Florida, 32806

  • Alkermes Investigational Site

    Philadelphia, Pennsylvania, 19118

  • Alkermes Investigational Site

    Pico Rivera, California, 90660

  • Alkermes Investigational Site

    Roswell, Georgia, 30076

  • Alkermes Investigational Site

    Salt Lake City, Utah, 84107

  • Alkermes Investigational Site

    San Diego, California, 92102

  • Alkermes Investigational Site

    South Miami, Florida, 33143

  • Alkermes Investigational Site

    Tucson, Arizona, 85712

  • Alkermes Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Adaptive Study of the Safety and Efficacy of RDC-0313 in Adults With Alcohol Dependence

This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.

Read the detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study. A 3-stage adaptive design will be used. Following screening, eligible subjects will be randomized equally to 1 of 4 groups (ALKS33 [RDC-0313] [1, 2.5, OR 10 mg], or matching placebo).

Being tested
ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg), ALKS33 (RDC-0313) (10 mg), Placebo
Medical subject headings
Alcoholism

What participants receive

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

  • ALKS33 (RDC-0313) (1 mg)Drug

    1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

  • ALKS33 (RDC-0313) (2.5 mg)Drug

    2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

  • ALKS33 (RDC-0313) (10 mg)Drug

    10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

  • PlaceboDrug

    Matching placebo taken once daily for 12 weeks

Study groups in NCT00981617
Study groupRoleWhat they receive
ALKS33 (RDC-0313) (1 mg)Experimental1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Receives: Drug: ALKS33 (RDC-0313) (1 mg)
ALKS33 (RDC-0313) (2.5 mg)Experimental2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Receives: Drug: ALKS33 (RDC-0313) (2.5 mg)
ALKS33 (RDC-0313) (10 mg)Experimental10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Receives: Drug: ALKS33 (RDC-0313) (10 mg)
PlaceboPlacebo comparatorMatching placebo (capsules without active study drug) provided for daily oral administration
Receives: Drug: Placebo

What is being measured

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

  1. Percent of subjects abstinent from heavy drinking

    Measured: 12 Weeks

Secondary outcomes (6)

  1. Percent of subjects abstinent from any drinking

    Measured: 12 Weeks

  2. Percent of days abstinent from heavy drinking

    Measured: 12 Weeks

  3. Percent of days abstinent from any alcohol

    Measured: 12 Weeks

  4. Number of drinks per drinking day

    Measured: 12 Weeks

  5. Days to relapse to first heavy drinking day

    Measured: 12 Weeks

  6. Incidence of Adverse Events

    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 posted22 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

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
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00981617
Sponsor's protocol ID
ALK33-005
Status last verified
Aug 2011
First submitted
21 Sep 2009
Last updated
23 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • O'Malley SS, Todtenkopf MS, Du Y, Ehrich E, Silverman BL. Effects of the Opioid System Modulator, Samidorphan, on Measures of Alcohol Consumption and Patient-Reported Outcomes in Adults with Alcohol Dependence. Alcohol Clin Exp Res. 2018 Oct;42(10):2011-2021. doi: 10.1111/acer.13849. Epub 2018 Aug 13.

    PubMed 30055046

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg) and ALKS33 (RDC-0313) (10 mg) in people with Alcohol Dependence, run by Alkermes, Inc. at 27 sites 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 10 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 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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?

Percent of subjects abstinent from heavy drinking (time frame: 12 Weeks). 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 NCT00981617, 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 23 Aug 2011.

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