Pregabalin effect on opioid withdrawal symptoms

Assessment of adding Pregabalin to daily treatment regimen in reducing withdrawal symptoms in opioid dependent patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201702012266N6

Enrollment

Registered

2017-04-11

Start date

2015-01-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

opiod withdrawal symptoms.

Interventions

Intervention 1: Intervention group: Pregabalin tab, oral administration, 150mg/day in 1st week, 300mg/day in 2nd week and 450mg/day in 3rd and 4th weeks. Intervention 2: Control group: placebo tab, or

Treatment - Drugs

Intervention group: Pregabalin tab, oral administration, 150mg/day in 1st week, 300mg/day in 2nd week and 450mg/day in 3rd and 4th weeks

Control group: placebo tab, oral administration, one tab for 1st week, 2 tabs for 2nd week and 3 tabs for 3rd and 4th weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: being drug dependent based on DSM-V criteria; regular oral/smoking daily consumption of opium; using no other medication including psychiatric drugs and also other substances except cigarette; not using pain medications; absence of other comorbid psychiatric disorders; not having any special diseases in which addiction treatment is prohibited; no contraindication for pregabalin consumption; no use of any other medication interacting with pregabalin. Exclusion criteria: lack of patients' interest for participation in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Opioid withdrawal symptoms including; feeling sick; stomach cramps; muscle spasms or twitching; feeling cold; heart pounding; muscular tension;aches and pains;yawning;runny/watery eyes; difficulty sleeping. Timepoint: At the begining of the intervention initiation, at the end of 1st week, at the end of 2nd week and at the end of 3rd and 4th weeks. Method of measurement: based on SHOWS questionnaire.	—

Measure

Time frame

Opioid withdrawal symptoms including; feeling sick; stomach cramps; muscle spasms or twitching; feeling cold; heart pounding; muscular tension;aches and pains;yawning;runny/watery eyes; difficulty sleeping. Timepoint: At the begining of the intervention initiation, at the end of 1st week, at the end of 2nd week and at the end of 3rd and 4th weeks. Method of measurement: based on SHOWS questionnaire.

—

Secondary

Measure	Time frame
Side effects including; Vertigo; Drowsiness; Fatigue; Weight Gain; Tremor; Constipation; Mouth dryness. Timepoint: end of 1st week, end of 2nd week, end of 3rd week and end of 4th week. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahryar Moazeni

Isfahan University of Medical Sciences

shahryar.m1984@gmail.com+98 31 3222 2475

Outcome results

None listed

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