Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Intervention1: moxonidine in combination with buprenorphine- naloxone: Assessment tools at baseline, 7 days and 14 days. After 14 days, all the participants will be given oral Naltrexone (25 mg /day)
Sponsors
Govt Medical College Rajindra Hospital Patiala
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient should fulfill the criteria of opioid use disorder as DSM-5. 2. Patient should be in withdrawal state at the time of admission (should fulfill the DSM-5 criteria of opioid withdrawal syndrome). 3. Should be in the age group of 18 to 50 yrs. 4. Patients who will give voluntary informed consent for detoxification.
Exclusion criteria
Exclusion criteria: 1. The patients who are diagnosed with any major physical illness, organic brain disease, epilepsy, schizophrenia, other psychosis or mental retardation will be excluded. 2. Current alcohol abusers or those taking any other drugs along with opioids will also be excluded. 3. Patients whose BP 4. Patients with bradycardia (heart rate 5. Pregnant and breast feeding women are to be excluded. 6. Elderly of age > 60 yrs are excluded. 7. Patients on Beta blockers, Calcium channel blockers, Tricyclic antidepressants, Digitalis that interact adversely with Clonidine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures will be success of detoxification, therapeutic efficacy on CGI, craving assessment on VAS and withdrawal response on improvement in Clinical Opioid Withdrawal Scale (COWS) and Subjective Opioid Withdrawal Scale (SOWS).Level of motivation will be assessed on SOCRATES-8D scale. Timepoint: Primary outcome measures will be assessed at baseline, at 7 days and at 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of the drugsassessed onADR scale, well being on SF ââ?¬â?? 36 scale, retention on Naltrexone treatment and relapse rates in three month follow-up.Timepoint: Three months | — |
Countries
India
Contacts
Public ContactDr Parvarjot Kaur
Government Medical College and Rajindra Hospital ,Patiala
Outcome results
None listed