SmokingPhase 2MEPNCT03593538
Effects of Metformin During Nicotine Withdrawal
A Phase 2 study testing Metformin in people with Smoking and HIV-1-infection, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, HIV-1-infection
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 13 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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:
- Anti-anxiety or panic disorder medications (e.g., clonazepam, alprazolam).
- Anti-psychotic medications as assessed on a case-by-case basis
- Glucophage/metformin
- Glyburide
- Furosemide or digoxin
- Nifedipine
- Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)
- Participants who report taking prescription opiate-containing medications (Duragesic/fentanyl patches, Percocet, Oxycontin) will require physician approval prior to confirming final eligibility.
- Current use of any smoking cessation medications (e.g., Chantix/varenicline, Zyban/bupropion, nicotine replacement therapy/gum/patch).
- For safety reasons, HIV-infected smokers taking dolutegravir (Tivicay) or drugs that contain dolutegravir (e.g., Triumeq) should not take more than 1000 mg of metformin per day. Therefore, individuals taking dolutegravir will be force randomized to either the placebo condition or the low dose condition.
- Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study. After final eligibility is confirmed, subjects who report taking contraindicated medication(s) over the course of the study period may only remain eligible if the Study Physician and/or Principal Investigator determines that the contraindicated medication(s) do/did not impact the study design, data quality, and/or subject safety/welfare. Subjects are permitted to take necessary prescription medications not included within the exclusion list during the study.
- General Exclusion:
- Current, anticipated, or pending enrollment in another research program over the next 2-3 months that could potentially affect subject safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
- Not planning to live in the area for the next two months.
- Color blindness.
- Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
- Known allergy to study medication.
- Planned radiologic studies involving the use of intravascular iodinated contrast materials (e.g., intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials) during the course of study participation.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
- Not able to effectively communicate in English (reading, writing, speaking).
- Missing 3 or more doses during the medication period determined by self-report.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effects of Metformin on Mood and Cognition During Nicotine Withdrawal
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.
Read the detailed description
There is a need for novel approaches to optimize smoking cessation treatment to help more smokers quit. Mood disturbance and cognitive deficits during nicotine withdrawal may be important treatment targets given their association with smoking relapse. In addition, factors such as HIV-1 infection may exacerbate abstinence effects on mood and cognitive deficits and thus should be measured and controlled for. The investigators hypothesize that the FDA-approved medication, metformin, will attenuate withdrawal-related mood disturbance and cognitive deficits, controlling for HIV status. Using a well-validated abstinence challenge paradigm, the investigators propose a placebo-controlled double-blind parallel arm study with one between-subjects factor of medication (low dose: 500 mg, high dose: 1500 mg, and placebo). Non-treatment seeking smokers (HIV-: n=54; 18 per group) will complete this 23 day study.
- Conditions
- Smoking, HIV-1-infection
- Being tested
- Metformin, Placebo
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Metformin capsule
PlaceboDrug
Also called Placebo (for Metformin)
Sucrose filler in gel capsules
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Metformin | Experimental | Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day Receives: Drug: Metformin; Drug: Placebo |
| High Dose Metformin | Experimental | Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day Receives: Drug: Metformin |
| Placebo | Placebo comparator | Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood Following 24h of Smoking Abstinence
Self-reported mood on the Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format measure that assesses Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset). The minimum value for each subscale is 10 and the maximum value is 50. Higher scores indicate greater positive or negative affect.
Measured: Day 23
Cognitive Function Following 24h of Smoking Abstinence
Composite score of computer-based neurocognitive tasks (N-back Working Memory Task, Stop Signal Task, Hopkins Verbal Learning Test - Revised [HVLT-R]) designed to test working memory and attention. A standardized z-score (mean=0, standard deviation=1) was calculated for the primary outcome for each task and an average was computed from the three z-scores. Higher scores indicated better cognitive performance.
Measured: Day 23
Secondary outcomes (5)
Self-reported Smoking Behavior
Cigarettes smoked per day as reported on the Timeline Follow-Back (TLFB). Cigarettes smoked per day is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which uses a 24-hr time reference.
Measured: Days 7, 14, 21, and 23
Self-reported Withdrawal Symptoms
The "Minnesota Nicotine Withdrawal Scale - Revised version"(MNWS_R) captures the current state of nicotine withdrawal. The scale assesses eight DSM-IV items of nicotine withdrawal including: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, decreased heart rate, difficulty concentrating, restlessness, and increased appetite/weight gain. Participants rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe and a summary score will be calculated. Withdrawal is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which uses a 24-hr time reference. The scale ranges from 0 to 32 with higher scores indicating more severe withdrawal symptoms.
Measured: Days 7, 14, 21, and 23
Self-reported Craving for Cigarettes
The 10-item brief Questionnaire of Smoking Urges (QSU-B) assesses craving for cigarettes. The QSU-B contains 2 sub-scales (anticipation of reward, relief from negative affect) which are summed to create the total score. Similar to withdrawal symptoms, craving is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which will use a 24-hr time reference. Items are rated from 1 (strongly disagree) to 7 (strongly agree) and are summed to create a total score ranging from 10 to 70. Higher scores indicate higher levels of craving.
Measured: Days 7, 14, 21, and 23
Subjective Effects of Smoking
The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations and comprise 3 scales: satisfaction score, psychological relief score, and toxicity score. Each scale is the average of items with a minimum value of 1 and a maximum value of 7. Higher scores indicate more satisfaction, greater psychological relief, and higher subjective toxicity, respectively.
Measured: Days 7, 14, 21, and 23
Subjective Sensory Experience of Smoking
The Rose Sensory Questionnaire (SQ), a 9-item Likert-format measure, assesses how much participants liked the cigarette smoked (liking scale) and how high in nicotine the cigarettes appeared to be (strength scale). The questionnaire also includes a diagram of the respiratory tract and asks participants to rate the strength of the cigarette puffs on their tongue, nose, back of mouth and throat, windpipe, and chest. Each scale is the average of items with a minimum value of 1 and a maximum value of 7. Higher scores indicate greater liking and perceived strength, respectively.
Measured: Days 7, 14, 21, and 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Apr 2016
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Principal investigator, Robert Schnoll, University of Pennsylvania
- Investigators
- Robert Schnoll, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593538
- Sponsor's protocol ID
- 824504
- Acronym
- MEP
- Status last verified
- Mar 2021
- First submitted
- 25 Jun 2018
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin on Mood and Cognition During Nicotine Withdrawal
- ClinicalTrials.gov ID
- NCT03593538
- Acronym / sponsor ID
- MEP / 824504
- Conditions
- Smoking, HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is a need for novel approaches to optimize smoking cessation treatment to help more smokers quit. Mood disturbance and cognitive deficits during nicotine withdrawal may be important treatment targets given their association with smoking relapse. In addition, factors such as HIV-1 infection may exacerbate abstinence effects on mood and cognitive deficits and thus should be measured and controlled for. The investigators hypothesize that the FDA-approved medication, metformin, will attenuate withdrawal-related mood disturbance and cognitive deficits, controlling for HIV status. Using a well-validated abstinence challenge paradigm, the investigators propose a placebo-controlled double-blind parallel arm study with one between-subjects factor of medication (low dose: 500 mg, high dose: 1500 mg, and placebo). Non-treatment seeking smokers (HIV-: n=54; 18 per group) will complete this 23 day study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Metformin | Experimental | Drug: Metformin, Drug: PlaceboDays 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day |
| High Dose Metformin | Experimental | Drug: MetforminDays 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboDays 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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:
Key exclusion criteria (46 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: GlucophageMetformin capsule | Drug | High Dose Metformin, Low Dose Metformin |
| PlaceboAlso: Placebo (for Metformin)Sucrose filler in gel capsules | Drug | Low Dose Metformin, Placebo |
Primary outcome
Mood Following 24h of Smoking Abstinence
Time frame: Day 23
Self-reported mood on the Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format measure that assesses Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset). The minimum value for each subscale is 10 and the maximum value is 50. Higher scores indicate greater positive or negative affect.
Cognitive Function Following 24h of Smoking Abstinence
Time frame: Day 23
Composite score of computer-based neurocognitive tasks (N-back Working Memory Task, Stop Signal Task, Hopkins Verbal Learning Test - Revised [HVLT-R]) designed to test working memory and attention. A standardized z-score (mean=0, standard deviation=1) was calculated for the primary outcome for each task and an average was computed from the three z-scores. Higher scores indicated better cognitive performance.
5 secondary outcomes
Self-reported Smoking Behavior
Time frame: Days 7, 14, 21, and 23
Self-reported Withdrawal Symptoms
Time frame: Days 7, 14, 21, and 23
Self-reported Craving for Cigarettes
Time frame: Days 7, 14, 21, and 23
Subjective Effects of Smoking
Time frame: Days 7, 14, 21, and 23
Subjective Sensory Experience of Smoking
Time frame: Days 7, 14, 21, and 23
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Schnoll, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Smoking and HIV-1-infection, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Following 24h of Smoking Abstinence (time frame: Day 23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.