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Effect of Metformin on Nicotine Withdrawal Syndrome reduction and Nicotine Abstinence increasing, a Double-Blind Placebo-Controlled Trial; the Results of 12-Month Follow-Up

Effect of Metformin on Nicotine Withdrawal Syndrome reduction and Nicotine Abstinence increasing, a Double-Blind Placebo-Controlled Trial; the Results of 12-Month Follow-Up

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190221004
Enrollment
Unknown
Registered
2019-02-21
Start date
2015-02-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

This study was including people who were volunteered for smoking cessation

Interventions

Metformin (Aria&#44
based on the reported side effects&#44
started with the baseline dosage of 500 mg (one tablet) daily in the first to fourth weeks and reached to a dosage of 1000 milligrams daily (two Tablets) from the fourth to the eighth week and reached
size&#44
and taste. Providing the medication and placebo was done by two nurses who were unaware about the study groups.
Experimental Drug,Placebo Comparator Drug
Metformin ,placebo

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Eligibility criteria were: of the age range was 18-65, average smoking rate of at least five cigarettes in a day (PCD) for at least one year, avoiding from smoking in the enrolment phase for at least seven days, BMI at the range of 18-35, not using any psychiatric medication or receiving psychological interventions in the three months that lead up to the study and desire to reduce or stop smoking and obtain informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria were: diagnosis of diabetes mellitus or high blood pressure or any side effects such as seizure or dizziness, liver, and kidney disease, heart disease, severe infection, lactic acidosis susceptibility, severe burn, dehydration, surgery, trauma, diabetic coma; ketoacidosis; epilepsy or any condition that may reduce the seizure threshold, including neuronal anorexia, neuronal overeating, active brain tumors, symptoms of dystonia, or simultaneous alcohol drinking , benzodiazepine, psychoactive drugs that less than a year has been past from their abstinence, female patients who were breast-fed or had a positive human Chorionic Gonadotropin (hCG) test. The use of Digoxin, Morphin, Cimetidine, Amiloride, Calcium channel blockers, Ranitidine, Triamterene, Procainamide, Quinine, Trimethoprim, and Vancomycin that are excreted by renal tubular transport, increase plasma metformin concentrations and interfere with renal clearance.

Design outcomes

Primary

MeasureTime frame
depression, anxiety, cravings, stimulation-enthusiasm, and difficulty in concentration 12 weeks Fagerstrom Test for Nicotine Dependence, Cigarette Withdrawal Scale

Secondary

MeasureTime frame
urinary cotinine levels 12 weeks Urinary cotinine assessments and exhaled carbon monoxide

Countries

iran

Contacts

Public Contactbijan pirnia

Bijan Center for Substance Abuse Treatment, tehran, iran

b.pirnia@usc.ac.ir+9802122081450

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026