Effectiveness of Pregabalin on Sleep Quality in Patients Receiving Methadone Maintenance Treatment

Effectiveness of Pregabalin on Sleep Quality in Patients Receiving Methadone Maintenance Treatment: A Randomized double blind Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015021121045N1

Enrollment

140

Registered

2015-11-12

Start date

2016-01-10

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

SUBSTANCE DEPENDENCY. A cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences

Interventions

Intervention 1: intervention group will receive one capsule (75 milligram) before sleep for 8 week. Intervention 2: control group will receive one capsule same shape and color with pregabalin befo

Treatment - Drugs

intervention group will receive one capsule (75 milligram) before sleep for 8 week.

control group will receive one capsule same shape and color with pregabalin before sleep for 8 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: History of heroin dependency; patients under methadone maintenance treatment Exclusion criteria: Age under 18 year and older than 75; starting methadone maintenance treatment less than 6 month; PSQ sleep quality questionnaire score less than 5; patients with severe sleep disorder who need special treatment or major depressive disorder or psychosis based on psychiatrist visit; Participants with methadone maintenance dose lower than 60 mg/day or higher than 120 mg/day; Participant with using sedative- hypnotic drugs or heroin or methamphetamine during 8 week intervention

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: before intervention,week 4,week 8. Method of measurement: Pittsburgh sleep quality questionaire.	—

Secondary

Measure	Time frame
Drug side effects. Timepoint: week 1-8,weekly. Method of measurement: standard side effects checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr seyed kaveh Hojjat

North khorasan university of MedicalSciences,Addiction and Behavioral Sciences Research Center

k.Hojjat@Nkums.ac.ir+98 582211009

Outcome results

None listed

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