Steps in testing a new medication for Meth Addiction: Step one- phase I clinical trials

Hi. This is Dr. Heinzerling, Medical Director of UCLA SARx and the topic of this entry is the first step in the clinical testing of potential medications for methamphetamine addiction: Phase I clinical trials. When we begin testing a potential medication as a treatment for meth addiction, the first thing that must be assessed is whether the medication is safe and tolerable in patients with meth addiction. In particular, there is always the concern that a medication we might want to use to treat meth addiction may inadvertently cause side effects that could be dangerous. A particular issue in meth addiction is if the medication increases the effect of meth on the heart. Meth alone causes an increase in pulse and blood pressure. If the medication we are testing interacts with meth such that the increase in pulse and/or blood pressure is GREATER with the combo of the medication plus meth than it is with meth alone, then this could be dangerous as patients in the clinic will likely use meth on top of the medication before they are able to completely quit.

To find out if a medication is likely to be safe, we have volunteers who use meth go into the hospital (in our case at Harbor-UCLA) where we can observe them very closely. We then have them take the medication and give them small doses of pharmaceutical methamphetamine. We monitor them very closely for any possible side effects and of course treat any possible complications. We also ask them how it feels to get the dose of meth on the medication compared to on a placebo pill to see if the medication might reduce the effects of meth as this could signal it will help in treating meth addiction. If all goes well, the patients tolerate the medication in combo with a low dose of meth and we are able to move the medication to the next step in development: phase II clinical trials (more on this in another posting soon!).

These types of studies are very important in order to learn how patients who use meth react to a new medication. It is not possible to test a medication in the clinic before completing this type of safety study in the hospital. These studies also require that the patients stay in the hospital for a significant amount of time and as a result, participants are compensated for their time commitment. These studies are NOT appropriate for people who want to quit meth as the study does not provide treatment to quit meth, only to see how people who use meth tolerate the mew medication. Anyone who is interested in participating in one of these studies or would like additional info can check out the clinical trials section of the website or call 866-449-UCLA and talk to one of our representatives.

As usual let us know if you have questions or comments either on the website or via out Twitter feed (UCLASARx). Thanks for tuning in.



Tags: clinical trial, crystal meth, harbor-ucla, keith heinzerling, medication safety, phase 1

When is INPATIENT or RESIDENTIAL treatment for drug/alcohol problems needed?

Hello! Dr. Heinzerling here again for another blog entry. Today's topic is another one that I frequently receive questions about: "Do I need an inpatient/residential treatment program?" A common misconception is that getting treatment for a drug or alcohol problem involves living for a time at a "rehab." Actually, most treatment for drug or alcohol problems in the US is provided in outpatient settings. Inpatient (usually in a hospital setting) and/or residential (where patients live for a period at the treatment program) can play a very important role for particular patients but is not always required. The best way to find out if a patient needs an inpatient or residential program is to speak with a professional addiction health care provider (a doctor or counselor/therapist) who can assess the patient and determine whether inpatient or residential treatment is the best option. Below are some general points that addiction professionals usually take into account in deciding whether to recommend inpatient/residential treatment (this info should not substitute for the advice of a health care professional!):

•  Residential/inpatient treatment is usually indicated for patients with severe medical and/or psychiatric conditions in addition to drug/alcohol problems. Inpatient treatment allows doctors to more closely monitor the medical/psychiatric condition and provide more intensive treatment. 
• Residential treatment is best for patients who are homeless or do not have a safe place to stay. In addition, patients living in an environment where drug/alcohol use is highly prevalent may need to be in a residential program to escape the triggers that are common in their usual environment. 
• Patients who have been unable to control drug/alcohol use during outpatient treatment may need a period in a more controlled environment to establish even initial drug/alcohol abstinence.
• In addition, some patients may need a medical/inpatient detoxification to prevent serious medical complications from withdrawal symptoms, especially in the case of alcohol and benzodiazepines. This is an issue that definitely requires consultation with a medical doctor.

Clearly, inpatient/residential programs can provide more intensive treatment than outpatient programs but also are more expensive and may disrupt the patient's life (i.e. not possible to continue with work or family responsibilities during treatment).Patients can maintain some of their normal activities and pursue outpatient treatment, but it is critical to also arrange for significant support (such as attending self-help groups and support from family and friends) to supplement outpatient treatment as the patient will continue to be exposed to drug/alcohol triggers in the outpatient setting. On the other hand, patients who do inpatient or residential treatment eventually have to learn to control drug/alcohol problems outside of the inpatient setting and outpatient treatment most directly prepares patients for this. One final thought is that another option is an outpatient treatment program combined with a sober living facility, which is a place to stay where everyone is committed to NOT using drugs or alcohol (sober livings are NOT treatment programs but can provide critical support to patients during outpatient treatment).

Well thanks for tuning in and remember that the best way to determine if you would do better with an inpatient or outpatient program is to consult with a health care professional with expertise in addiction! I hope this info helps you to better be able to ask your health care provider the right questions that will help you to decide what course to take. As always feedback is welcome on our website (www.uclasarx.org) or via our twitter feed (uclasarx).



Tags: faq, inpatient, keith heinzerling, misconceptions, outpatient, residential

Is there a pill that can cure addiction?

Hello! Dr. Heinzerling here to talk about a question patients often ask: "Is there a pill that can cure addiction?" There is currently no pill that can solve a drug or alcohol problem on its own. No pill will make it easy to deal with a drug/alcohol problem and there is no pill that will change a person who is not motivated to change. In short, pills don't solve problems, people solve problems. BUT, we know from data and experience that many people who are highly motivated and try very hard still fail with existing non-pharmacologic addiction treatments, which typically combine behavioral counseling and support. With that in mind, a medication added to standard counseling and support services can boost the success rate of patients getting treatment for drug/alcohol problems.

This makes sense based on research and experience that shows that addiction has biological, psychological, AND social aspects. As a result, the best treatment should be one that addresses all three of these domains:

1. a medication for the biology of addiction,
2. a counseling program for the psychology of addiction,
3. and a support program for the social aspects of addiction.

This support program may include self-help groups such as AA or SMART Recovery; support (emotional and otherwise) from family, friends, clergy, community members, sponsors; and an environment and surroundings that support abstinence from drugs/alcohol (avoid triggers such as people, places, and things). In other words, we do not expect medications to be able to REPLACE counseling and support but instead to AUGMENT them. And we also know that generally treatment outcomes are best when a medication is combined with behavioral therapy and support. With this in mind, the treatment we provide in our clinics as well as in our clinical trials combines medication with counseling and support services. What type of counseling and support is provided may be different for each patient depending on their particular needs and which types of counseling/support work best with which medications is an area of active research.

Well that's all for now. Thanks for checking in and as always feel free to send us feedback and comments via our twitter feed (uclasarx)!



Tags: addiction medicine, counseling, cure, keith heinzerling, medication, support

Rx Stimulants for Methamphetamine Addiction? Good idea?

Hi and welcome back. Dr. Heinzerling here again. In response to our last entry, several people have asked, "What about using prescription stimulants to treat methamphetamine addiction?" GREAT IDEA and one with precedent. Nicotine replacement (patches) is used for smoking cessation treatment and methadone and buprenorphine (Suboxone) are approved to treat opioid addiction. This approach is called SUBSTITUTION THERAPY.

Several studies have assessed this approach for stimulant addiction. A randomized, placebo controlled trial tested oral sustained-release methamphetamine (pharmaceutical tablets not street methamphetamine) for treating cocaine addiction. Cocaine use was lower in patients receiving oral methamphetamine compared to those receiving placebo (60% of urine tests positive for cocaine in placebo group compared to 20% positive in sustained-release methamphetamine patients). A different study tested oral sustained-release d-amphetamine for methamphetamine addiction. Patients getting d-amphetamine had lower cravings and withdrawal symptoms but did not use less methamphetamine (the dose of d-amphetamine was relatively low and higher doses may have better results). So it seems that substitution treatment DOES have some beneficial effects in stimulant addiction, although it may be better at reducing drug use than stopping it completely.

Continue reading the rest of this entry »

Tags: cocaine, crystal meth, methadone, methamphetamine, stimulants, suboxone, substitition treatment

Medications to treat Methamphetamine Addiction: How close are we?

Hi! This is Dr. Keith Heinzerling, Medical Director of UCLA SARx and welcome back to our Addiction Medicine blog. Today’s entry regards a topic we have spent quite a bit of time working on: medications to treat methamphetamine addiction. Currently there are no medications approved to treat meth addiction. Typical treatment for methamphetamine addiction currently involves counseling, usually cognitive behavioral therapy. Contingency management, where patients receive immediate reinforcement for not using drugs, is also effective for methamphetamine addiction but has not been widely implemented. While these behavioral treatments do work, they are not effective in 100% of cases. As a result, we are interested in developing a medication or medications that could be combined with these behavioral treatments to increase the success rate.

One important thing to note here is that we do NOT think that there will be medications in the near future that are strong enough to treat a methamphetamine problem on their own. Medications will likely be most effective in combination with a good counseling program and strong support (self-help groups, family, friends, etc.).

So far, only one medication has consistently shown an effect in clinical trials: bupropion, which is also known as Wellbutrin (the anti-depressant) and Zyban (smoking cessation medication).

Continue reading the rest of this entry »

Tags: addiction medicine, behavioral, bupropion, clinical trial, crystal meth, ibudilast, keith heinzerling, medications, methamphetamine

Welcome to our newly designed website

Dr. Keith Heinzerling

Hello. I'm Dr. Keith Heinzerling, Medical Director of the UCLA Substance Abuse Pharmacotherapy Unit. On behalf of Dr. Steven Shoptaw, Director of UCLA SARx, and the entire UCLA SARx staff, I'd like to welcome you to our newly redesigned website! We hope the site, along with our @UCLASARx twitter feed, will be a way for us to better communicate with you about who we are, what we are doing, and exciting new developments in the science of Addiction Medicine. You can find information on the site about how you can participate in one of our methamphetamine clinical trials as well as info on the treatment services we offer for a variety of substances including opioids and alcohol. Also check back here frequently for blog entries from myself and other SARx staff with information on how scientific research is revolutionizing Addiction Medicine treatment. Finally, I'd like to recognize the UCLA SARx staff, particularly Maria Sipin, for their hard work in making this new site possible! I hope you enjoy the site and thanks for visiting!



Tags: about us, keith heinzerling, welcome

Harbor-UCLA Research Opportunity for Crystal Meth Users

Are you using crystal meth? Interested in participating in a research study?

Volunteers are sought for a study to examine the safety of a combination of a medication (ibudilast) and methamphetamine. To participate, you must be at least 18 years old and have a recent history of methamphetamine use. Your participation will last up to 29 days with a 27-night stay as an inpatient at the Harbor-UCLA hospital. Participation includes taking study medications. Participants may be compensated up to $841. This is not a treatment protocol for methamphetamine dependence.

Click this link to read more about ibudilast and the purpose of this research study.

To find out if you may be qualified to participate, call (866) 449-8252 and ask about the inpatient research study.



Tags: compensation, ibudilast, inpatient, not for treatment, phase 1, research study, safety interaction trial, volunteers

Safety Interaction Trial for Ibudilast and Methamphetamine

This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people.

For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information.

This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.

Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment.

Read more about our safety interaction trial for ibudilast and methamphetamine at ClinicalTrials.gov.



Tags: clinical trial, crystal meth users, harbor-ucla, ibudilast, methamphetamine, safety, ucla

Alcohol Addiction Treatment in Los Angeles

Our doctors provide confidential, office-based, medical treatment for alcohol dependence using FDA-approved medications, including naltrexone, acamprosate, and Vivitrol®, a once a month anti-alcoholism shot.

For treatment information, call Dr. Heinzerling's office at (310) 319-4700.

Read about Vivitrol from PubMed Health.



Tags: acamprosate, addiction, alcohol, los angeles, naltrexone, outpatient, santa monica, treatment, ucla, ucla family health center, vivitrol

Stimulants Addiction Treatment in Los Angeles

Get help for an addiction to cocaine and methamphetamine

While no FDA-approved medications for stimulant dependence are currently available, patients may be eligible to enroll in one of our clinical trials of experimental anti-addiction medications.

Call (866) 449-UCLA for more information.



Tags: addiction, cocaine, los angeles, methamphetamine, outpatient, santa monica, stimulants, treatment, ucla, ucla family health center

Opioids Addiction Treatment in Los Angeles

Get help for an addiction to heroin and prescription pain killers such as Vicodin® and Oxycontin®

Our doctors provide confidential, office-based, medical treatment for opioid dependence using FDA-approved medications such as Suboxone® (buprenorphine/naloxone) and Vivitrol®, a once a month anti-opioid shot.

For treatment information, call Dr. Heinzerling's office at (310) 319-4700.



Tags: addiction, anti-opioid shot, buprenorphine, heroin, los angeles, naloxone, opioids, outpatient, oxycontin, pain killers, santa monica, suboxone, treatment, ucla family health center, vicodin, vivitrol

Marijuana Addiction Treatment in Los Angeles

While no FDA-approved medications for marijuana dependence are currently available, our doctors may prescribe medication if appropriate.

For treatment information, call Dr. Heinzerling's office at (310) 319-4700.



Tags: addiction, los angeles, marijuana, outpatient, santa monica, treatment, ucla, ucla family health center

Tobacco Addiction Treatment in Los Angeles

Get help for your tobacco addiction

Our doctors can help patients quit smoking using FDA-approved smoking cessation medications including nicotine replacement, Zyban® (bupropion), and Chantix® (varenicline). In particular, our doctors specialize in helping patients who have tried to quit smoking before and failed.

For treatment information, call Dr. Heinzerling's office at (310) 319-4700.

Read more about addiction:

• Become an Ex Smoker: Re-learn Life Without Cigarettes
• California Smokers' Helpline: 1-800-NO-BUTTS
• Southern California Intergroup of Nicotine Anonymous

Tags: addiction, bupropion, chantix, fda-approved, outpatient, quit smoking, santa monica, smoking cessation, tobacco, treatment, ucla family health center, varenicline, zyban

Our Treatment Philosophy

Tags: addiction medicine, counseling, medications, support, treatment philosophy, ucla sarx

Keith Heinzerling

Steven Shoptaw

UCLA Vine Street Clinic (Hollywood)

UCLA Family Health Center (Santa Monica)

UCLA SARx in the Community

Staff

Research Papers

2010

• Randomized, double-blind, placebo-controlled trial of modafinil for the treatment of methamphetamine dependence (link)

2009

• Treatment for amphetamine withdrawal (link)
• Predicting adherence to treatment for methamphetamine dependence from neuropsychological and drug use variables (link)
• The cardiovascular and subjective effects of methamphetamine combined with γ-vinyl-γ-aminobutyric acid (GVG) in non-treatment seeking methamphetamine-dependent volunteers (link)

2008

• Randomized, placebo-controlled trial of bupropion for the treatment of methamphetamine dependence (link)
• Bupropion Hydrochloride versus Placebo, in Combination with Cognitive Behavioral Therapy, for the Treatment of Cocaine Abuse/Dependence (link)

2006

• Randomized, placebo-controlled trial of baclofen and gabapentin for the treatment of methamphetamine dependence (link)

We tweet-- start following today!

Read our latest tweets @UCLASARX and start following us today. We have lots of information about local services, advancements in medicine, FAQs on addiction, current events and everything else in between.

Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

The purpose of this study is to find out if bupropion can help adolescents (age 14-21) reduce or stop using methamphetamine.

This is a pilot study to determine the feasibility of a randomized, double-blind clinical trial of bupropion versus placebo, in conjunction with cognitive behavioral therapy and contingency management targeting attendance, among adolescents with methamphetamine abuse. Results of the study are essential to designing a phase II clinical trial adequately powered to determine the efficacy of bupropion for methamphetamine abuse among adolescents. Read more about our bupropion pilot trial for teen methamphetamine abuse at ClinicalTrials.gov.



Tags: adolescents, bupropion, methamphetamine, teens

Clinical Research Trial: Study of Medical Treatment for Methamphetamine Addiction (Bupropion)

The purpose of the study is to determine if bupropion 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.

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 makeup may influence whether or not they respond to treatment with bupropion for methamphetamine addiction.

Call (866) 449-8252 if you or someone you know are interested in this outpatient study.

Read more about our bupropion study for methamphetamine addiction at ClinicalTrials.gov.



Tags: addiction, bupropion, clinical trial, crystal meth, los angeles, methamphetamine, ucla

Using meth and having trouble stopping?

UCLA is conducting a study of medical treatment for meth addiction at the UCLA outpatient research site in Hollywood. Counseling, study medication and compensation available for qualified participants.

Call (866) 449-8252 for appointments and more information.

Read more about our bupropion study for methamphetamine addiction.