Methamphetamine DependencePhase 1VareniclineNCT01571167
Varenicline as a Treatment for Methamphetamine Dependence
A Phase 1 study testing Varenicline in people with Methamphetamine Dependence and Methamphetamine Abuse, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Dependence, Methamphetamine Abuse, Substance Abuse
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In order to participate in the study, participants must:
- Be English-speaking volunteers who are not seeking treatment at the time of the study
- Be between 18-55 years of age
- Meet DSM-IV TR criteria for MA dependence
- Must be cigarette smokers, defined as smoking 10 or more cigarettes per day by self-report
- Have a self-reported history of using MA by the smoked or IV route and provide at least one MA-positive urine prior to admission
Show all 10Show fewer
- Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150 mm Hg systolic and 45-90 mm Hg diastolic; this criterion must be met within 2 days of admission
- Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal
- Have a baseline EKG that demonstrates normal sinus rhythm, normal conduction (including QTc), and no clinically significant arrhythmias
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician or nurse practitioner and the principal investigator.
Who cannot join
- Subjects will be excluded if they:
- Have any previous medically adverse reaction to METH, including loss of consciousness, chest pain, or epileptic seizure
- Have neurological or psychiatric disorders, as assessed by MINI, such as: episode of major depression within the past 2 years; lifetime history of schizophrenia, other psychotic illness, or bipolar illness; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months and/or current suicidal ideation/plan; history of psychosis occurring in the absence of current METH use
- Meet DSM-IV criteria for abuse/dependence on alcohol or other drugs, except nicotine or marijuana
- Have used methamphetamine only by the intravenous route
- Have evidence of clinically significant heart disease or hypertension, as determined by physician
Show all 20Show fewer
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Have HIV and currently symptomatic, have a diagnosis of AIDS, or currently taking antiretroviral medication
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, and throughout the study
- Have any history of asthma, chronic coughing and wheezing, or other chronic respiratory illnesses
- Currently use alpha or beta agonists, theophylline, or other sympathomimetics
- Have made a suicide attempt in the past year
- Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of study.
- Criteria for Discontinuation Following Initiation:
- Positive urine drug screen or breath test indicating illicit use of cocaine, MA, alcohol, opiates, or other abused drugs not delivered as part of this protocol
- Inability to comply with study procedures
- Meet discontinuation criteria due to exaggerated response to MA, described below
- Nausea severe enough to require treatment.
- Rationale for Subject Selection Criteria:
- Participants are required to have used MA by the smoked or IV route to avoid exposing participants to routes of administration that produce more intensive interoceptive effects. The age criteria were selected primarily to avoid enrolling participants with undiagnosed cardiovascular disease. Participants with active HIV disease are excluded to avoid potential exacerbation of their underlying disease; participants with asymptomatic HIV are included because this group is at high risk for MA dependence. Participants with asthma (or who take asthma medications) are excluded due to potential adverse interactions between beta agonist medications and MA.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
Official title: A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine
The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
Read the detailed description
This study is part of an effort to develop treatments for methamphetamine abuse. Varenicline is a drug that changes levels of certain brain chemicals that may also be useful in helping people to stop using methamphetamine. Our goal is to determine the safety and effects of varenicline (1 and 2 mg, daily, vs. a placebo) when it is used before experimental administration of methamphetamine, on a number of physical and psychological measures; specifically blood pressure, heart rate, and how you feel after taking methamphetamine. The secondary purpose is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on the reinforcing effects of methamphetamine by measuring methamphetamine self-administration in methamphetamine-dependent human volunteers.
- Being tested
- Placebo, Varenicline
- Keywords
- Methamphetamine, Chantix, Varenicline
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
Participants will receive varenicline or matched placebo from day 1 through day 7, then the same subjects will return within 2-4 weeks and assigned to each of the two remaining study medication conditions, and undergo the identical procedures (3-phase study).
VareniclineDrug
Also called Chantix
For varenicline 1 mg, dosing will begin at 0.5 mg once daily (with 0 mg placebo to maintain blind of bid dosing) for days 1-3, will be increased to 0.5 mg twice daily for the days 4-6, and then reduced to 0.5 mg once daily on day 7. No medication is given on Day 8.
VareniclineDrug
Also called Chantix
For varenicline 2 mg, dosing will begin at 0.5 mg once daily for days 1-3 (with 0 mg placebo to maintain blind of bid dosing), will be increased to 0.5 mg twice daily for day 4, and increased to 1 mg twice daily on days 5-6, and then reduced to 1 mg once daily on day 7. No medication is given on Day 8.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Varenicline 2 mg | Active comparator | Not described Receives: Drug: Varenicline |
| Varenicline 1 mg | Active comparator | Not described Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of varenicline and methamphetamine on safety and cardiovascular measures
The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements. Digital 12-lead ECG will also be recorded prior to randomization. Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing. In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.
Measured: On study day 6 and 7
Secondary outcomes (1)
The effects of varenicline and methamphetamine on subjective effects
Efficacy will be assessed by measuring effects of treatment on subjective effects produced by administration of MA. Patients will complete visual analog scale (VAS) ratings at T= 5, 15, 30, 60, 120, 240 and 360 min post dosing. Other diagnostic measures and assessment instruments will be used to further characterize the study population.
Measured: On study day 6 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
- Investigators
- Richard De La Garza, II, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571167
- Sponsor's protocol ID
- H-26875
- Other IDs
- DPMC, 1R01DA027134-01
- Acronym
- Varenicline
- Status last verified
- Jun 2013
- First submitted
- 20 Feb 2012
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kalechstein AD, Mahoney JJ 3rd, Verrico CD, De La Garza R 2nd. Short-term, low-dose varenicline administration enhances information processing speed in methamphetamine-dependent users. Neuropharmacology. 2014 Oct;85:493-8. doi: 10.1016/j.neuropharm.2014.05.045. Epub 2014 Jun 12.
PubMed 24930359Verrico CD, Mahoney JJ 3rd, Thompson-Lake DG, Bennett RS, Newton TF, De La Garza R 2nd. Safety and efficacy of varenicline to reduce positive subjective effects produced by methamphetamine in methamphetamine-dependent volunteers. Int J Neuropsychopharmacol. 2014 Feb;17(2):223-33. doi: 10.1017/S146114571300134X.
PubMed 24393456
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine
- ClinicalTrials.gov ID
- NCT01571167
- Acronym / sponsor ID
- Varenicline / H-26875
- Keywords
- Methamphetamine, Chantix, Varenicline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
Detailed description
This study is part of an effort to develop treatments for methamphetamine abuse. Varenicline is a drug that changes levels of certain brain chemicals that may also be useful in helping people to stop using methamphetamine. Our goal is to determine the safety and effects of varenicline (1 and 2 mg, daily, vs. a placebo) when it is used before experimental administration of methamphetamine, on a number of physical and psychological measures; specifically blood pressure, heart rate, and how you feel after taking methamphetamine. The secondary purpose is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on the reinforcing effects of methamphetamine by measuring methamphetamine self-administration in methamphetamine-dependent human volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Varenicline 2 mg | Active comparator | Drug: Varenicline |
| Varenicline 1 mg | Active comparator | Drug: Varenicline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be English-speaking volunteers who are not seeking treatment at the time of the study
- Be between 18-55 years of age
- Meet DSM-IV TR criteria for MA dependence
- Must be cigarette smokers, defined as smoking 10 or more cigarettes per day by self-report
- Have a self-reported history of using MA by the smoked or IV route and provide at least one MA-positive urine prior to admission
Key exclusion criteria (20 listed)
- Have any previous medically adverse reaction to METH, including loss of consciousness, chest pain, or epileptic seizure
- Have neurological or psychiatric disorders, as assessed by MINI, such as: episode of major depression within the past 2 years; lifetime history of schizophrenia, other psychotic illness, or bipolar illness; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months and/or current suicidal ideation/plan; history of psychosis occurring in the absence of current METH use
- Meet DSM-IV criteria for abuse/dependence on alcohol or other drugs, except nicotine or marijuana
- Have used methamphetamine only by the intravenous route
- Have evidence of clinically significant heart disease or hypertension, as determined by physician
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 |
|---|---|---|
| PlaceboAlso: Sugar pillParticipants will receive varenicline or matched placebo from day 1 through day 7, then the same subjects will return within 2-4 weeks and assigned to each of the two remaining study medication conditions, and undergo the identical procedures (3-phase study). | Drug | Placebo |
| VareniclineAlso: ChantixFor varenicline 1 mg, dosing will begin at 0.5 mg once daily (with 0 mg placebo to maintain blind of bid dosing) for days 1-3, will be increased to 0.5 mg twice daily for the days 4-6, and then reduced to 0.5 mg once daily on day 7. No medication is given on Day 8. | Drug | Varenicline 1 mg |
| VareniclineAlso: ChantixFor varenicline 2 mg, dosing will begin at 0.5 mg once daily for days 1-3 (with 0 mg placebo to maintain blind of bid dosing), will be increased to 0.5 mg twice daily for day 4, and increased to 1 mg twice daily on days 5-6, and then reduced to 1 mg once daily on day 7. No medication is given on Day 8. | Drug | Varenicline 2 mg |
Primary outcome
The effects of varenicline and methamphetamine on safety and cardiovascular measures
Time frame: On study day 6 and 7
The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements. Digital 12-lead ECG will also be recorded prior to randomization. Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing. In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.
1 secondary outcome
The effects of varenicline and methamphetamine on subjective effects
Time frame: On study day 6 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Derived from this study: PubMed 24930359Kalechstein AD, Mahoney JJ 3rd, Verrico CD, De La Garza R 2nd. Short-term, low-dose varenicline administration enhances information processing speed in methamphetamine-dependent users. Neuropharmacology. 2014 Oct;85:493-8. doi: 10.1016/j.neuropharm.2014.05.045. Epub 2014 Jun 12.
- Derived from this study: PubMed 24393456Verrico CD, Mahoney JJ 3rd, Thompson-Lake DG, Bennett RS, Newton TF, De La Garza R 2nd. Safety and efficacy of varenicline to reduce positive subjective effects produced by methamphetamine in methamphetamine-dependent volunteers. Int J Neuropsychopharmacol. 2014 Feb;17(2):223-33. doi: 10.1017/S146114571300134X.
Related trials for Methamphetamine Dependence
Active, not recruiting
The Human Stress Response in a Simulated ED Setting
Stress Physiology, Stress Reaction
Recruiting
rTMS for Craving in Methamphetamine Use Disorder
Methamphetamine Abuse, Substance Use Disorders
Active, not recruitingPhase 3
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Methamphetamine-dependence, Methamphetamine Abuse
RecruitingPhase 2
Glutide for Ending Methamphetamine
Methamphetamine-dependence
RecruitingPhase 2
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Methamphetamine Abuse, Methamphetamine-dependence
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.
Richard De La Garza, II, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varenicline in people with Methamphetamine Dependence and Methamphetamine Abuse, run by Baylor College of Medicine 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 10 inclusion and 20 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 13 Jun 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effects of varenicline and methamphetamine on safety and cardiovascular measures (time frame: On study day 6 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571167, which also lists 2 linked publications.
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 13 Jun 2013.