Study of Medical Treatment for Methamphetamine Addiction - Full Text View

Purpose

Currently there are no medications approved for the treatment of methamphetamine addiction. Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for the treatment of depression and for cigarette smoking cessation but is not approved by the FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that bupropion may help people receiving treatment for methamphetamine addiction to reduce or to stop their methamphetamine use. But results of these studies also suggest that bupropion may help certain groups of patients more than others, such as men versus women and light versus heavy methamphetamine users, although the reasons for this difference are not known. One possibility is that a person's genetic make up may influence whether or not they respond to treatment with bupropion for methamphetamine addiction.

The purpose of the study is to determine if bupropion is can help people reduce or stop their methamphetamine use and to investigate whether genetic variations influence whether people respond to treatment with bupropion for methamphetamine addiction, which may help doctors and patients better decide if treatment with bupropion will be beneficial or not. To identify possible genetic variations that influence response to bupropion, we will perform genetic tests on blood or saliva specimens from participants receiving treatment with either bupropion or placebo (which is a pill that contains no medication) in conjunction with standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use, as assessed with urine drug screens, among participants receiving bupropion versus those receiving placebo to determine if bupropion helps people to reduce or stop their methamphetamine use. We will then compare the results of the genetic tests among participants who respond and who do not respond to bupropion. In addition, since the amount of methamphetamine a person uses was associated with response to bupropion in preliminary studies, we will also compare the results of genetic testing among persons with heavy versus light methamphetamine use before entering treatment.

Results of this study have the potential to provide insights into the biology of methamphetamine addiction and help increase the understanding of how bupropion works. This information could be useful to develop effective medications for methamphetamine addiction and to improve the ability of clinicians to provide treatment to patients with methamphetamine addiction.

Condition	Intervention	Phase
Methamphetamine Amphetamine Dependence Pharmacogenetics Methamphetamine Dependence Substance Abuse	Drug: Bupropion	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pharmacogenomics and Medication Development for Methamphetamine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Methamphetamine Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Treatment Effectiveness Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
End of Treatment Methamphetamine Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)

Secondary Outcome Measures:

Treatment Retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	84
Study Start Date:	January 2009
Study Completion Date:	July 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Bupropion Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.	Drug: Bupropion Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks. Other Names: Zyban Wellbutrin
Placebo Comparator: Sugar Pill	Drug: Bupropion Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks. Other Names: Zyban Wellbutrin

Arms

Assigned Interventions

Active Comparator: Bupropion

Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.

Drug: Bupropion

Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.

Other Names:

Zyban
Wellbutrin

Placebo Comparator: Sugar Pill

Drug: Bupropion

Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.

Other Names:

Zyban
Wellbutrin

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older;
meet DSM-IV criteria for methamphetamine dependence;
seeking treatment for MA problems;
specific range of methamphetamine use in the 30 days prior to study entry;
willing and able to comply with study procedures, including genotyping;
willing and able to provide written informed consent;
if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

Exclusion Criteria:

have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID or a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID;
currently on prescription medication that is contraindicated for use with bupropion;
have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
have a history of alcohol dependence within the past three years;
have a history of a seizure disorder;
have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
have a history of anorexia or bulimia;
have current hypertension uncontrolled by medication, or any other circumstances that, in the opinion of the investigators, would compromise participant safety;
have a history of sensitivity to bupropion.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833443

Locations


United States, California
UCLA Clinical Research Site 910 Vine St
Los Angeles, California, United States, 90038

Sponsors and Collaborators

University of California, Los Angeles

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Keith G Heinzerling, MD MPH	UCLA Dept of Family Medicine

More Information

Additional Information:

UCLA Substance Abuse Pharmacotherapy Unit This link exits the ClinicalTrials.gov site

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heinzerling KG, Swanson AN, Hall TM, Yi Y, Wu Y, Shoptaw SJ. Randomized, placebo-controlled trial of bupropion in methamphetamine-dependent participants with less than daily methamphetamine use. Addiction. 2014 Nov;109(11):1878-86. doi: 10.1111/add.12636. Epub 2014 Aug 5.


Responsible Party:	Keith Heinzerling, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00833443 History of Changes
Other Study ID Numbers:	KH_K23, P50DA018185, K23DA023558, DPMC
Study First Received:	January 30, 2009
Results First Received:	January 10, 2014
Last Updated:	January 10, 2014
Health Authority:	United States: Food and Drug Administration United States: NIH/NIDA California: Research Advisory Board of California California: UCLA Data Safety and Monitoring Board for Addiction Medicine

Keywords provided by University of California, Los Angeles:


Methamphetamine Addiction Pharmacogenomics Amphetamine	Bupropion Meth Crank Crystal

Additional relevant MeSH terms:


Bupropion Methamphetamine Adrenergic Agents Adrenergic Uptake Inhibitors Antidepressive Agents Antidepressive Agents, Second-Generation Autonomic Agents Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents	Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sympathomimetics Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

Study of Medical Treatment for Methamphetamine Addiction (BUP PGx)