On March 4, we received notification that our application was denied review because TSM is a stand-alone pharmacological treatment that does not mandate the inclusion of behavioral or psychosocial treatments. Below is our response. Please feel free to share this open letter with any one you feel will benefit from its message.
Project Director, SAMHSA NREPP
Development Services Group, Inc.
March 14, 2016
I am extremely disappointed by the decision of the Substance Abuse and Mental Health Services Administration (SAMHSA) to decline review of The Sinclair Method (TSM) for inclusion in the National Registry of Evidence-based Programs and Practices (NREPP) based solely on the fact that it is not “combined with one or more behavioral or psychosocial treatment(s).” It is my opinion as the Executive Director of the C Three Foundation that your agency’s reluctance to include stand-alone pharmacological treatments of FDA-approved medications is in direct conflict with definitions, information, and statistics provided by SAMHSA to the general public and medical professionals, the perpetuation of dangerous barriers to alcohol use disorder treatment, and is ultimately contradictory to the values of your organization.
Alcohol Use Disorder – “To be diagnosed with an AUD, individuals must meet certain diagnostic criteria. Some of these criteria include problems controlling intake of alcohol, continued use of alcohol despite problems resulting from drinking, development of a tolerance, drinking that leads to risky situations, or the development of withdrawal symptoms. The severity of an AUD—mild, moderate, or severe—is based on the number of criteria met.” (http://www.samhsa.gov/disorders/substance-use)
By SAMHSA’s own definition, a person with the “development of a tolerance” to alcohol could be diagnosed as having mild AUD. The same could be said about problems controlling intake of alcohol, where a person feels compelled by a biological craving to drink beyond his or her intentions. These criteria can be the result of genetics or biological sources of addiction and do not necessarily indicate behavioral therapy is needed. TSM (targeted use of naltrexone to reduce or terminate biological cravings that lead to increased drinking) addresses these physical indicators of AUD in ways behavioral and psychosocial treatments cannot because TSM addresses the alcohol deprivation effect, which is a biological craving caused by a sudden withdrawal from and continued abstinence from alcohol. Why should people be taught to manage cravings and triggers when TSM can help them eliminate them instead?
Co-occurring Disorder – “Mental and substance use conditions often co-occur. In other words, individuals with substance use conditions often have a mental health condition at the same time, and vice versa.” (http://www.samhsa.gov/co-occurring)
By SAMHSA’s definition, substance use disorders are not mental health conditions. While they may often co-occur, they can present independently of one another. The policy of SAMHSA, which excludes stand-alone pharmacological treatments such as TSM for review as an evidence-based treatment, reinforces the antiquated belief that those who suffer from AUD are mentally ill and, therefore, in need of the same behavioral and psychosocial treatments given to those with mental health issues in order to experience a full and lasting recovery.
TSM is ideal for those who do not present with a mental illness. It can be administered via a primary care physician, nurse practitioner, or any other medical professional licensed to prescribe medications. For those who do present with a co-occurring mental illness, TSM plus additional therapy addresses has been shown in practice as beneficial to more than 75% of those in treatment.
Information about Naltrexone
The SAMHSA website notes the biological function of naltrexone. “When used as a treatment for alcohol dependency, naltrexone blocks the euphoric effects and feelings of intoxication. This allows people with alcohol addiction to reduce their drinking behaviors enough to remain motivated to stay in treatment and avoid relapses. Naltrexone is not addictive nor does it react adversely with alcohol. Long-term naltrexone therapy extending beyond three months is considered most effective by researchers, and therapy may also be used indefinitely.” (http://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone)
SAMHSA’s own description of how naltrexone works is in line with published, peer-reviewed scientific research. TSM and pharmacological extinction can be derived from this information. “Naltrexone blocks the euphoric effects and feelings of intoxication” when taken with alcohol because the chemical process cannot block feelings of intoxication when there is no alcohol to block. This results in reduced drinking without triggering the harmful alcohol deprivation effect.
In double-blind, placebo controlled studies with rats, naltrexone has been shown to work. Unless the rats were also subjected to one or more behavioral or psychosocial treatments, it is a direct contradiction of science and SAMHSA’s promotion of how naltrexone affects the endorphin system of a person with AUD to say the “evidence” of the treatment can only be effective when “combined with one or more behavioral or psychosocial treatment(s).”
“In 2014, among the 20.2 million adults with a past year [substance use disorder], 7.9 million (39.1 percent) had [any mental illness] in the past year.” (http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf)
According to the Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health national report prepared and distributed by SAMHSA, only 39.1% of those with an SUD also have mental illness. By mandating pharmacological treatments also include “one or more behavioral or psychosocial treatment(s)” to be considered for inclusion in the NREPP, the 60.9% of people with an SUD and no indication of mental illness are forced to accept mental illness-related treatments that they do not require and may be unable to afford as a condition of treatment.
In an informal survey conducted by the C Three Foundation in 2015, 60% of TSM users reported a reduction in drinking of 60% or more. Further, 82% reported no history of a mental illness diagnosis, 74% reported a family history of substance abuse, and 69% reported they had not had any alcohol-related legal issues. All of the respondents either found TSM on their own using the internet or because a family member had seen success using this treatment.
Reinforcing Dangerous Barriers
Barriers to Stigma Reduction
“The diagnoses of alcohol dependence and abuse, as well as hazardous alcohol use, continue to carry significant social stigma that affects both the person who is alcohol dependent and healthcare providers. This stigma continues to exist, in part, because of a lack of understanding of alcohol dependence as a treatable medical disorder.” (http://store.samhsa.gov/shin/content/SMA13-4380/SMA13-4380.pdf)
SAMHSA’s current policy on the review of evidence-based treatments states, “FDA–approved pharmacotherapy interventions (on-label use) are considered for NREPP review only when combined with one or more behavioral or psychosocial treatment(s).” However, this policy is counterproductive to reducing the stigma associated with AUD as it implies the cause is an issue of behavior that can be chosen with a strong sense of will power or a mental illness. There is mounting evidence of the role genetics plays in addiction. Behavioral and psychosocial treatments cannot effectively address genetic predispositions to alcohol addiction. TSM, however, can.
Barriers to Prevention
“Prevention, treatment, and recovery support services for behavioral health are important parts of the health service systems for the community.” (http://www.samhsa.gov/about-us/who-we-are)
TSM is an ideal prevention tool for those with mild to moderate AUD because it overcomes several important barriers to seeking treatment.
- By removing the mandate to abstain from alcohol forever, those who are beginning to have concerns about their drinking are able to address the biology of their cravings on their terms.
- Given the ability to address drinking patterns discretely without having to make major life changes, individuals are able to avoid the public stigma associated with declaring themselves "alcoholics."
- They are able to reduce harmful drinking without triggering the alcohol deprivation effect, which increases chances of long-term success.
- For those in need of mental health services, individuals are better able to focus on triggers, behaviors, relationships, etc. without the constant preoccupation with and nagging feelings of physical cravings for alcohol.
- Naltrexone is generic and has a 20-year history of scientific research and safety guidelines. It is cost effective for those on TSM and for insurance providers and it is more effective than forced abstinence, which has a high rate of relapse.
- Primary care treatment eliminates the need for costly specialists.
- Because TSM only utilizes naltrexone when drinking for a targeted response, there is no need for daily pills. Further, if a person decides after pharmacological extinction has occurred that they no longer wish to drink alcohol (applies to about 40% of those on TSM), then there is no need to continue taking naltrexone.
TSM does not require a “rock bottom” moment or mentality. It is an effective way to prevent harmful drinking such as binge drinking from progressing into physical addiction and severe AUD.
Contradictory to Values
“SAMHSA's mission is to reduce the impact of substance abuse and mental illness on America's communities.” (http://www.samhsa.gov/about-us/who-we-are) However, the agency’s refusal to include stand-alone pharmacological treatments stands in direct conflict with this mission. This refusal is one of the many reasons why, by SAMHSA’s own account, “last year alone, close to 20 million people in need of substance abuse treatment did not receive it. (http://www.samhsa.gov/about-us/who-we-are)
“SAMHSA also seeks to support the most effective treatment methods possible through its programs, this includes support of evidence-based programs and treatments. Evidence-based programs are programs that have been shown to have positive outcomes through high quality research.” (http://www.samhsa.gov/treatment)
Treatment providers turn to SAMHSA as an authority on evidence-based treatments for alcohol use disorder. The Sinclair Method meets every other criteria listed for review in the NREPP (http://nrepp.samhsa.gov/04f_reviews_submission.aspx). Those criteria include:
- Research or evaluation of the intervention has assessed mental health or substance use outcomes among individuals, communities, or populations OR other behavioral health-related outcomes on individuals, communities, or populations with or at risk of mental health issues or substance use problems.
- Evidence of these outcomes has been demonstrated in at least one study using an experimental or quasi-experimental design. Experimental designs require random assignment, a control or comparison group, and pre- and post-intervention outcome assessments. Quasi-experimental designs do not require random assignment, but do require a comparison or control group and pre- and post-intervention outcome assessments. Comparison/ control groups must be a no-treatment control group, a wait-list control group, a treatment-as-usual comparison group, or an intervention that is presumed to be ineffective or substantially less effective than the intervention (e.g., a “placebo” control or, in cases in which providing no treatment might be considered unethical, less effective treatments, even if not treatment-as-usual, such as “supportive therapy”). Studies with single-group, pretest-posttest designs or single-group, longitudinal/multiple time series do not meet this requirement, but will be considered to identify emerging programs and practices for consideration in the Learning Center.
- The results of these studies have been published in a peer-reviewed journal or other professional publication, or documented in a comprehensive evaluation report, published within the previous 25 years. Comprehensive evaluation reports must include a review of the literature, theoretical framework, purpose, methodology, findings/results with statistical analysis and p values for significant outcomes, discussion, and conclusions.
“SAMHSA strives to ensure that Americans can access effective prevention and treatment services for mental and substance use issues, particularly for those with the most serious conditions.” (http://www.samhsa.gov/disorders)
The Sinclair Method for treating alcohol use disorder is an effective prevention and treatment that should be included in SAMHSA’s National Registry of Evidence-based Programs and Practices.
Jenny R Williamson
C Three Foundation