Effects of Metformin During Nicotine Withdrawal

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking, HIV-1-infection

In brief

The purpose of this study is to test the effects of a medication called metformin (Glucophage®) on smoking behavior. This medication is FDA-approved for treatment of type-2 diabetes. It is being used for research purposes in this study. Participants will be randomized to one of 3 treatment groups: low dose of metformin, high dose of metformin, or placebo.

Key facts

Study ID: NCT03593538
Run by: University of Pennsylvania
People needed: 80
Starts: 2016-04-01
Expected to finish: 2020-03-13
Last updated by the study team: 2021-03-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Eligible subjects will be males and females:
18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average for the past 6 months.
HIV status
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment.
HIV-uninfected smokers: no diagnosis of HIV, either via blood test or self-report.
Must not currently be interested in quitting smoking.
Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are in the study and using transdermal nicotine.
If current or past diagnosis of bipolar disorder, eligible if:
No psychotic features
MADRS: total score less than 8 (past 4 weeks), suicidal item score less than1 (past 4 weeks)
Y-MRS: total score less than 8 (past 4 weeks), irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)
No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
No aggressive or violent acts or behavior in the past 6 months
Able to communicate fluently in English.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.

You may not qualify if…

Smoking Behavior:
Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months.
Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes.
Alcohol/Drugs:
Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months. Subjects will be told to limit or avoid the use of alcohol while in the study to avoid any adverse reactions to the study medication.
Current untreated and unstable diagnosis of substance dependence (eligible if past use and if receiving treatment and stable for at least 30 days). Current untreated and unstable diagnosis of substance abuse requires Study Physician approval.
A positive urine drug screen for cocaine, amphetamines, methamphetamines, PCP, barbiturates and ecstasy (MDMA)at Intake, or any testing session (see Measures and Table 1 for details). Participants believed to have a false-positive result may continue in the study, with investigator approval.
Medical:
Females who self-report current pregnancy, planning a pregnancy during the study, or currently breastfeeding/lactating. All female subjects of child-bearing potential shall undergo a urine pregnancy test at the Intake, Baseline, PQ-Testing and 24-H Testing sessions.
Current diagnosis of unstable and untreated major depression, as determined by self-report \& MINI (eligible if stable for at least 30 days).
Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.
Suicide risk as indicated by at least one of the following on the MINI/CSSRS (the PI \&/or PM [LCSW] will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):
Current suicidal ideation (within 30 days of enrollment)
Two or more lifetime suicide attempts or episodes of suicidal behavior
Any suicide attempt or suicidal behavior within 2 years of enrollment
Self-reported kidney and/or liver disease or transplant untreated/unstable or within the past 6 months.
Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months.
Type-1 or type-2 diabetes.
Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*.
Liver function tests more than 20% outside of the normal range; Gamma-glutamyl Transpepsidase (GGT) values more than 20% outside of the normal range. If Albumin/Globulin ratios are 20% outside of normal range the abnormal value will be evaluated for clinical significance by the Study Physician and eligibility will determined on a case-by-case basis.
Renal disease or renal dysfunction (e.g., serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females]).
A blood glucose level less than 70 mg/dl at any visit.
Participants presenting with SBP greater than 159 mmHg and/or DBP greater than 99 mmHg at the Intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be ineligible to participate, unless determined otherwise by the Study PI or Study Physician, upon review.
Medication:
Current use or recent discontinuation (within the past 14 days) of any of the following medications:

Where it is running

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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