Skip to content

Does Gabapentin Help relieve Restless leg Syndrome In patients stopping Opioid use.

Effectiveness of Gabapentin for Restless Leg Syndrome in Opioid Withdrawal: A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080879
Enrollment
132
Registered
2025-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: BUPRENORPHINE AND GABPENTIN: Tablet Buprenorphine will be given Sub lingually in the dose ranges of 2-16mg based on the tolerability for 14 days and the frequency is divided into one to
the dose will be increased by 300mg every 2-3 days up to a maximum dose of 1200mg per day depending on the tolerability and severity of the patients
the total dose being divided into twice daily and thrice daily dosing which will be given for total duration of 14 days. The dose of Gabapentin will be tapered down by 300mg per day in the next 1 week

Sponsors

Longjam Henbi Devi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed with Opioid dependence Syndrome (ODS) as per ICD-10, undergoing Buprenorphine induction. 2. Patients with opioid withdrawal (COWS) 3. Written Informed Consent

Exclusion criteria

Exclusion criteria: 1. The presence of severe mental illness affecting the interview. 2. Co-morbid medical conditions which can contribute to RLS like Iron deficiency anaemia, diagnosed Diabetes Mellitus with peripheral Neuropathy, diagnosed Rheumatic Disease, diagnosed peripheral Neuropathy, diagnosed Parkinson s Disease, Fibromyalgia and Spinocerebellar ataxia.

Design outcomes

Primary

MeasureTime frame
The score of the RLS rating scaleTimepoint: 2 weeks

Secondary

MeasureTime frame
1. Severity of RLS symptoms in opioid withdrawal patients. 2. Leeds Sleep Evaluation Questionnaire score. 3. Number of drop outs Timepoint: 1-2 weeks

Countries

India

Contacts

Public ContactDiptadhi Mukherjee

Lokopriya Gopinath Bordoloi Regional Institute of Mental Health

diptadhimukherjee@gmail.com9433780660

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026