to compare combination of Buprenorphine-naloxone with moxonidine versus clonidine in opioid detoxificatio

Phase 4

Conditions: Health Condition 1: F112- Opioid dependence

Registration Number: CTRI/2022/07/043760

Lead Sponsor: Govt Medical College Rajindra Hospital Patiala

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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 < 90/60 mmHg will also be excluded for the risk of severe hypotension.

4.Patients with bradycardia (heart rate < 50 beats/minute), severe bradyarrhythmia, malignant arrhythmia, heart failure or severe renal impairmentare excluded.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: Primary outcome measures will be assessed at baseline, at 7 days and at 14 days. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
safety of the drugsassessed onADR scale, well being on SF Ã¢â?¬â?? 36 scale, retention on Naltrexone treatment and relapse rates in three month follow-up.Timepoint: Three months