Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02195817 |
|
Recruitment Status :
Terminated
(The study was terminated due to enrolment challenges)
First Posted : July 21, 2014
Last Update Posted : February 28, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Dependence | Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A Other: Initial psychosocial support: Cohort B | Phase 4 |
635 patients are planned (total number of patients) with 475 patients treated with Selincro® (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction in alcohol consumption in patients with alcohol dependence.
Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by World Health Organization (WHO) as >60g alcohol/day for a man or >40g alcohol/day for a woman), or above, in the period between the Screening and Inclusion Visits.
Cohort B will comprise patients who reduce their alcohol consumption in the period between the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according to the SmPC).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 378 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care |
| Actual Study Start Date : | August 2014 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
|
Selincro® 18 mg with continuous psychosocial support: Cohort A
Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
|
Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
Other Name: nalmefene |
|
Initial psychosocial support: Cohort B
Initial psychosocial support followed by usual care practice, 12-week Observational Period
|
Other: Initial psychosocial support: Cohort B |
- Change in the number of Heavy Drinking Days (HDDs) (days/month) [ Time Frame: Baseline to Month 3 ]Cohort A
- Change in Total Alcohol Consumption (TAC) (g/day) [ Time Frame: Baseline to Month 3 ]Cohort A
- Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below [ Time Frame: Baseline to Month 3 ]Cohort A
- RLDRL response; defined as a downward shift in DRL to low DRL or below [ Time Frame: Baseline to Month 3 ]Cohort A
- Response defined as ≥70% reduction in TAC [ Time Frame: Baseline to Month 3 ]Cohort A
- Response defined as 0 to 4 HDDs (days/month) [ Time Frame: Month 3 ]Cohort A
- Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline to Week 12 ]Cohort A
- Clinical Global Impression - Global Improvement (CGI-I) [ Time Frame: Week 12 ]Cohort A
- y-glutamyl transferase (y-GT) [ Time Frame: Week 12 ]Cohort A
- Alanine aminotransferase (ALT) [ Time Frame: Week 12 ]Cohort A
- Aspartate aminotransferase (AST) [ Time Frame: Week 12 ]Cohort A
- Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom) [ Time Frame: Baseline to Week 12 ]Cohort A
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To ensure the study is broadly representative of primary care clinical practice, minimal inclusion and exclusion criteria are imposed with the main exclusion criteria relating to contraindications to the prescription of Selincro® and reflecting the indication wording in the SmPC.
Inclusion Criteria:
- The patient has alcohol dependence diagnosed according to ICD-10.
- The patient has had a high DRL in the 4 weeks preceding the Screening Visit.
- The patient is a man or woman, aged ≥18 years.
- The patient provides a stable address and telephone number.
Exclusion Criteria:
-
The patient has one or more contraindications to the prescription of Selincro®:
- hypersensitivity to the active substance or to any of the excipients
- taking opioid analgesics
- current or recent opioid addiction
- acute symptoms of opioid withdrawal
- recent use of opioids suspected
- severe hepatic impairment (Child-Pugh classification)
- severe renal impairment (eGFR <30 ml/min per 1.73 m2)
- a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
- The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >60g for men or >40g for women) in the 4 weeks preceding the Screening Visit.
- The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required.
- The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195817
Show 48 study locations
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT02195817 |
| Other Study ID Numbers: |
15892A 2013-004688-30 ( EudraCT Number ) |
| First Posted: | July 21, 2014 Key Record Dates |
| Last Update Posted: | February 28, 2017 |
| Last Verified: | February 2017 |
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Nalmefene Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |