Opiate Addiction
Conditions
Keywords
Opioid detoxification, Opioid antagonist induction, Conscious sedation
Brief summary
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.
Detailed description
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).
Interventions
DRUGNaltrexone
DRUGClonidine
DRUGLorazepam
Sponsors
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Opiate addiction * Use of short-acting opiate (morphine or heroine) * Age \> 18 years * Length of opiate addiction \> 1 year * Patient can make a decision for detoxification and has a capacity to consent for procedure * Written consent for procedure
Exclusion criteria
* Polyvalent addiction * Pregnancy or breast feeding * Cardiovascular pathology * Acute or chronic kidney disease * Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy) * Infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis) * Malnutrition (Nutritional risk screening 2002 score ≥3) * Diabetes mellitus * Previous history of psychosis * Glasgow coma scale \< 15 * Abdominal surgical intervention during last 30 days * Cumulative buprenorphine dose for stabilization \< 8 mg * Positive test for psychoactive substances during treatment * Refusal to participate in study at any point of it
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol levels | 2 days | Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention) |
| Adrenocorticotropic hormone (ACTH) levels | 2 days | Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress response levels according to blood pressure | 4 days | Blood pressure measurements were taken 4 times a day |
| Changes of potassium concentration due to stress response | 4 days | Blood samples were taken 3 times a day |
| Changes of sodium concentration due to stress response | 4 days | Blood samples were taken 3 times a day |
| Changes of chloride concentration due to stress response | 4 days | Blood samples were taken 3 times a day |
| Stress response levels according to heart rate | 4 days | Heart rate measurements were taken 4 times a day |
| Changes of glucose concentration due to stress response | 4 days | Blood samples were taken 3 times a day |
| Subjective Opiate Withdrawal Scale (SOWS) | 4 days | Patients were assessed with to SOWS 4 times a day |
| Objective Opiate Withdrawal Scale (OOWS) | 4 days | Patients were assessed with to OOWS 4 times a day |
| Changes of magnesium concentration due to stress response | 4 days | Blood samples were taken 3 times a day |
| Stress response levels according to respiratory rate | 4 days | Respiratory rate measurements were taken 4 times a day |
Countries
Lithuania
Outcome results
None listed