CTRI/2021/09/036462
Not yet recruiting
Phase 4
To Evaluate The Therapeutic Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use Disorder
GMC RH Patiala0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: F112- Opioid dependence
- Sponsor
- GMC RH Patiala
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female patients aged 18\-65 years with ICD\-10 diagnosis of Opioid Dependence.
- •2\.Patients who will bw mdeically stable.
- •3\.Patients who have given written informed consent.
Exclusion Criteria
- •1\. History of chronic psychosis or drug induced psychosis of any kind.
- •2\. Patients with paralytic ileus and respiratory depression.
- •3\. Pregnant women, lactating mothers, surgically\-sterile women or women who agree to continue using applicable birth control throughout the trial. All women of child\-bearing potential must have a negative urine pregnancy test.
- •4\. History of seizures, renal insufficiency or congestive heart failure.
- •5\. History of ketamine abuse/dependence or prior clinically significant adverse reaction to ketamine.
Outcomes
Primary Outcomes
Not specified
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