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The aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.
Study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. Patient is offered to take part in a study. Information is provided regarding protocol, aim and course of study. Patients who are eligible and consent for study commit to follow the pre-study recommendations.
Study consists of:
Primary assessment - information about study. Assessment of patient according to predefined criteria. Consent form. Allocation of the treatment date.
Stabilization - Buprenorphine. Assessment according to SOWS and OWS. Total amount of buprenorphine is recorded.
Repeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. If any test is positive patient is not enrolled to study.
Correction of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses.
Antagonist induction - patients receive opioid antagonist (incremental or standard dose). Withdrawal symptoms are assessed and correction with lorazepam is given if needed.
Data collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:
Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) |
|
| Control | Active Comparator | Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o Correction of symptoms for opioid abstinence: Clonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol levels | Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention) | 2 days |
| Adrenocorticotropic hormone (ACTH) levels | Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention) | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stress response levels according to heart rate | Heart rate measurements were taken 4 times a day | 4 days |
| Stress response levels according to respiratory rate | Respiratory rate measurements were taken 4 times a day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ROBERTAS BADARAS, MD | Vilnius University Clinic of Anaesthesiology and Intensive Care | Principal Investigator |
| JUOZAS IVASKEVICIUS, PROFESSOR | Vilnius University Clinic of Anaesthesiology and Intensive Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republic Vilnius University Hospital | Vilnius | Vilnius County | LT-04130 | Lithuania |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| D003000 | Clonidine |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Clonidine |
| Drug |
|
|
| Lorazepam | Drug |
|
|
| 4 days |
| Stress response levels according to blood pressure | Blood pressure measurements were taken 4 times a day | 4 days |
| Changes of potassium concentration due to stress response | Blood samples were taken 3 times a day | 4 days |
| Changes of sodium concentration due to stress response | Blood samples were taken 3 times a day | 4 days |
| Changes of chloride concentration due to stress response | Blood samples were taken 3 times a day | 4 days |
| Changes of magnesium concentration due to stress response | Blood samples were taken 3 times a day | 4 days |
| Changes of glucose concentration due to stress response | Blood samples were taken 3 times a day | 4 days |
| Subjective Opiate Withdrawal Scale (SOWS) | Patients were assessed with to SOWS 4 times a day | 4 days |
| Objective Opiate Withdrawal Scale (OOWS) | Patients were assessed with to OOWS 4 times a day | 4 days |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |