`
`ADVISORY
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`Breaking News for the Treatment Field
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` November 2002
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` Volume 2
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`Issue 1
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`GHB: A Club Drug To Watch
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`Treatment Guidelines for
`GHB Withdrawal
`Many clients who use GHB are not dependent on it and
`therefore can be educated about its risks and referred for
`outpatient therapy. However, clients with a history of
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`frequent dosing may experience withdrawal symptoms
`and require supervised medical detoxification. In these
`situations, providers should note the following:
`• GHB withdrawal and detoxification require
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`close medical supervision. Most clients require
`hospitalization ranging from 7 to 14 days.
`• Most people who become dependent on GHB find the
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`withdrawal symptoms unbearable and may try to self-
`medicate or self-detoxify with other drugs, including
`benzodiazepines, or alcohol. Using other substances
`in this way appears to contribute to withdrawal
`severity and may lead to respiratory depression,
`coma, and death.
`• Benzodiazepines can help ease some of the symptoms
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`of GHB withdrawal, particularly psychotic agitation, if
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`given in appropriate (and medically supervised) doses.
`• Other medications (e.g., barbiturates, anticonvulsants,
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`and antihypertensives) may be required to effectively
`manage GHB withdrawal and detoxification.
`• Another result of GHB withdrawal is amnesia or
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`memory loss, which greatly complicates a client’s
`treatment at every stage and “may contribute
`to a revolving door of treatment episodes and
`relapse when the patient has little awareness of
`the consequences of his or her GHB addiction.”*
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`Therefore, ongoing client education is critical.
`• Although clinicians have gained some insight
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`
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`
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`
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`into GHB dependence and withdrawal, research
`on treatment is an important area to be further
`developed. n
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`*Miotto, K., and Roth, B. “GHB Withdrawal Syndrome.”
`Austin: Texas Commission on Alcohol and Drug Abuse.
`
`What is GHB?
`Gamma hydroxybutyrate (GHB) is one of a group of
`club drugs that often are abused by people who attend
`
`a variety of all-night parties sometimes called “raves.”1
`
`In addition to GHB, the five drugs commonly identified
`as club drugs are lysergic acid diethylamide (LSD),
`ketamine, methamphetamine, methylenedioxymetham
`
`phetamine (MDMA, or ecstasy), and rohypnol
`(flunitrazepam).2
`
`GHB is a synthetically produced central nervous system
`depressant. On the street, it is usually sold as a liquid
`by the dose (a capful from a bottle or drops). In some
`cities, GHB is put into water guns, and users buy it by
`the squirt. In other instances, candy, such as a lollipop,
`is dipped in GHB and sold.3 In liquid form, GHB is
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`colorless and odorless and has a salty or soapy taste.4
`GHB is also sold in powder or capsule form. It is made
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`of lye or drain cleaner mixed with GBL, a
`chemical cousin of GHB and an industrial solvent
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`often used to strip floors. GBL itself is often abused
`and produces the same effects as GHB. GBL and
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`another chemical cousin, 1,4 butanediol (1,4 BD),
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`convert to GHB in the body. Recipes for GHB can
`easily be found on the Internet. Some GHB users brew
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`the drug in bathtubs at home.5
`Who uses GHB?
`
`The majority of GHB users are young adults. Many of
`these users do not realize that GHB affects each person
`differently or that differences in the purity and strength
`of the dose can mean the difference between life and
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`death. Misinformation on the Internet, a medium
`widely used by young adults, may also contribute to
`
`continued on reverse...
`
` U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`Substance Abuse and Mental Health Services Administration
`Center for Substance Abuse Treatment
`www.samhsa.gov
`
`
`
`JAZZ EXHIBIT 2007
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00547
`
`Page 1 of 4
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`November 2002, Volume 2, Issue 1
`Substance Abuse Treatment
`
`ADVISORY
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`GHB—again, including GBL—ranked 34th among 50
`most mentioned drugs in ED drug-related episodes.
`
`Why is GHB so dangerous?
`GHB, usually in combination with alcohol, was linked
`to more than 60 deaths from January 1992 to May 2001.
`Almost 60 percent of these deaths were people between
`ages 20 and 29. However, the number of GHB-related
`deaths may be underestimated because GHB does not
`remain in the body long and is usually not tested for at
`autopsy.1 GHB may be missed by many conventional
`
`urine drug screens.4
`The effects of GHB vary each time a person takes it, and
`it affects each person differently.4 A small increase in dose
`can increase the drug’s sedative effects to a lethal level.
`High doses of GHB may overwhelm the body’s ability to
`eliminate the drug; therefore, the effects are greater and
`last longer than expected.1
`The adverse effects of GHB include vomiting, seizure-like
`activity, loss of consciousness, respiratory arrest, coma,
`and death. GHB often is produced in clandestine laboratories;
`therefore, the purity and strength of doses vary. This
`
`situation makes it difficult for emergency personnel to
`obtain useful information on the amount of GHB that a
`person took.
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`
`
`How is GHB used in date rape?
`GHB has been slipped into unsuspecting victims’ drinks.
`GHB’s taste can be masked by adding it to a flavored
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`beverage. Because it is hard to detect GHB in a beverage,
`and because only small amounts are needed to achieve
`the desired effect, GHB has been used to facilitate rapes.
`Victims given GHB become unconscious and cannot
`defend themselves from these sexual assaults. They can
`not serve as witnesses in court because amnesia is another
`effect of consuming GHB.4
`GHB has been implicated in deaths as well. For instance,
`in January 1999, 15-year-old Samantha Reid was
`
`the problem. According to a report titled “Drugs and the
`Internet,” by the National Drug Intelligence Center, GHB
`is described on many Web sites as a relatively benign
`drug.6 Addiction and the possibilities of overdose and
`death generally are downplayed. The use of GHB as a
`date-rape drug is often dismissed as media hype.
`GHB use is most common among white, middle-class
`males between ages 13 and 30. GHB users are likely to use
`it with other drugs, particularly ecstasy.3 However, there
`are geographical and population variances in GHB use.
`[For instance, in New Orleans, there have been reports of
`GHB use among secondary school and college students,
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`whereas, in other areas, it is reputed to be widely accessible
`at gay male party venues.7]
`Bodybuilders have reported that they use GHB because it
`stimulates the release of growth hormones. People who are
`alcohol dependent may use it to try to eliminate alcohol
`cravings, even though there is no medical approval for this
`use in the United States.
`Despite the belief of some users that GHB is a safe body
`
`building or sleep aid, or a party drug that poses no risk for
`addiction or overdose, the effects of GHB can be tragic.
`The only legitimate use of GHB in the United States is for
`the treatment of cataplexy, a symptom of the sleep disorder
`narcolepsy in which muscles lose strength. The U.S. Food
`and Drug Administration approved GHB, under the brand
`name Xyrem, on July 17, 2002, but mandated some of the
`most severe restrictions ever imposed on a medicine.8
`
`Why has there been so much media
`attention focused on GHB lately?
`During the past decade, the use of GHB and GBL
`has increased. According to the Substance Abuse and
`Mental Health Services Administration’s (SAMHSA’s)
`Drug Abuse Warning Network (DAWN), the number
`of emergency department (ED) visits in which GHB is
`
`mentioned, including those in which GBL is mentioned,
`increased from 56 in 1994 to 4,969 in 2000.9 In 2000,
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`2
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`Substance Abuse Treatment
`
`ADVISORY
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`
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`November 2002, GHB: A Club Drug To Watch
`
`
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`What can treatment providers
`do to help?
` Providers should learn all they can about GHB—including
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`regional trends related to its use—because client educa
`
`tion about the dangers of GHB is critical, particularly as
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`reports of its euphoric effects may cause an increase in
`experimentation.
`Substance abuse treatment professionals should assess a
`client’s lifestyle and drug use habits before the client expe
`riences adverse effects and requires medical intervention.
`If a client is known to be experimenting with GHB or other
`club drugs, treatment providers should alert him or her to
`the adverse effects and provide emergency medical infor
`mation from a poison control center or appropriate health-
`
`care facility. Some experts suggest that clients with
`a history of bodybuilding be assessed for GHB abuse
`because this drug is commonly used in this patient popula
`
`tion.4 Providers should also warn clients that misinformation
`about GHB is available on the Internet. Many people who
`take the drug do not know of its dangers. For instance,
`only 9 GHB users in a study of 42 regular GHB users were
`aware that it could produce a withdrawal reaction.12 (See
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`the box on the back page for more information about
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`regular GHB users.)
`Knowing when patients need medical attention and
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`referring them to appropriate care are key. n
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`
`
`Notes
`1Whitten, L. “Conference Highlights Increasing GHB Abuse.”
`
`
` NIDA Notes. Bethesda, MD: National Institute on Drug
`
` Abuse. Retrieved April 5, 2002, from the World Wide Web,
`
`
`www.drugabuse.gov/NIDA_Notes/NNVol16N2/Conference.html.
`
`2Office of Applied Studies. “Club Drugs.” The DAWN Report.
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`Rockville, MD: Substance Abuse and Mental Health Services
`
`Administration, 10 pp., December 2000.
`
`3Executive Office of the President, Office of National Drug
`
`Control Policy. Pulse Check: Trends in Drug Abuse. ONDCP
`
`Pub. No. (NCJ) 191248. Washington, DC: Office of National
`
`Drug Control Policy, pp. 75–88, November 2001.
`
`
`3
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`“scooped” (the street term for slipping GHB into
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`someone’s drink). Reid lost consciousness and died the
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`
`next day.5 The teenage boys who scooped her drink were
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`sentenced to prison for manslaughter.10 Hillary J. Farias
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`was raped after being slipped GHB. On February 18,
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`2000, the Hillary J. Farias and Samantha Reid Date-Rape
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`Drug Prohibition Act of 2000 became law, making GHB a
`Schedule 1 drug.
`
`Do people on GHB develop
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`dependence and experience
`withdrawal symptoms?
`Severe GHB dependence was found to follow daily use
`of varying amounts of GHB over a period ranging from
`2 months to 3 years according to the findings in a retro
`spective study of eight patients with prolonged withdrawal
`symptoms after discontinuing chronic use of GHB.11
`Researchers found that withdrawal symptoms started
`between 1 and 6 hours after the last dose and lasted
`between 5 and 15 days. One person died from cardiac
`complications on the 13th day in the hospital. Reported
`withdrawal symptoms included:
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`• Psychosis and severe agitation requiring self-protection
`procedures and sedation
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`• Mild tachycardia (increased heart rate) and hypertension
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`• Neurologic effects, including prolonged delirium
`• Hallucinations
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`• Diaphoresis (profuse sweating), nausea, and vomiting.
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`What are the symptoms of a GHB
`overdose?
`Symptoms of GHB overdose include nausea, bradycardia
`(slow heart rate), and a decreased level of consciousness.
`
`Alcohol, opioids, barbiturates, and benzodiazepines
`potentiate the effects of GHB.12 In GHB overdoses, it is
`imperative to keep patients’ airways open, with assisted
`ventilation if necessary, and provide supportive care. GHB
`use should be considered when any patient presents with a
`coma of unknown origin.4
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`November 2002, Volume 2, Issue 1
`Substance Abuse Treatment
`
`ADVISORY
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`Survey of 42 Self-Reporting Regular GHB Users12
`Positive Effects of GHB Use—Euphoria, increased sex drive, and tranquility.
`Positive effects of GHB use, as compared with adverse
`Adverse Effects—Sweating and loss of consciousness (reported by 69 percent),
`experiences, were emphasized by participants. However,
`
`family members reported a “change in personality,” including
`nausea, auditory and visual hallucinations, headaches, vomiting, exhaustion,
`increased aggression, irritability, and memory problems.
`sluggishness, amnesia, confusion, and clumsiness.
`Rate of Use—18 participants used GHB 2 or 3 times daily, 12 participants
`Participants who used GHB with other substances reported
`more severe adverse events than those who used GHB alone. n
`4 or more times daily, and 12 participants once daily.
`
`Notes (continued)
`4Teter, C.J., and Guthrie, S.K. “A Comprehensive Review of
`MDMA and GHB: Two Common Club Drugs.” Pharmacotherapy
`21(12):1486–1513, 2001.
`5Cannon, A. “Sex, Drugs, and Common Death.” U.S. News and
`World Report, May 24, 1999.
`6National Drug Intelligence Center. “Drugs and the Internet—
`An Overview of the Threat to America’s Youth.” Retrieved
`April 30, 2002, from the World Wide Web, www.usdoj.gov/
`ndic/pubs/682.
`7Community Epidemiology Work Group. Epidemiologic
`Trends in Drug Abuse, Advanced Report. Bethesda, MD.
`National Institute on Drug Abuse, June 1999. Retrieved
`September 13, 2002, from the World Wide Web,
`165.112.78.61/CEWG/AdvancedRep/699ADV/699adv.html.
`8Center for Drug Evaluation. “FDA Drug Approvals List.” U.S.
`Food and Drug Administration. Retrieved July 31, 2002, from
`the World Wide Web, www.fda.gov/cder/whatsnew-date.htm.
`
`9Office of Applied Studies. Emergency Department Trends
`From the Drug Abuse Warning Network, Preliminary
`Estimates January–June 2001 With Revised Estimates 1994–
`2000. DAWN Series D-20. DHHS Pub. No. (SMA) 02–3634.
`Rockville, MD: Substance Abuse and Mental Health Services
`Administration, p. 104, 2002.
`10Associated Press. “Three Convicted in Date-Rape Drug
`Trial.” March 14, 2000. Retrieved September 13, 2002,
`from the World Wide Web, abcnews.go.com/sections/us/
`DailyNews/daterape000314.html.
`11Dyer, J.E.; Roth, B.; and Hyma, B.A. “Gamma-
`hydroxybutyrate Withdrawal Syndrome.” Annals of Emergency
`Medicine 37(2):147–53, 2001.
`12Miotto, K.; Darakjian, J.; Basch, J.; Murray, S.; Zogg, J.;
`and Rawson, R. “Gamma-hydroxybutyric Acid: Patterns
`of Use, Effects, and Withdrawal.” American Journal on
`Addictions 10(3):232–41, 2001.
`
`Substance Abuse Treatment Advisory
`This Advisory was written and produced under contract number 270-99-7072 by the Knowledge Application Program (KAP),
`a Joint Venture of The CDM Group, Inc., and JBS International, Inc., for the Center for Substance Abuse Treatment (CSAT),
`Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services (HHS).
`Disclaimer: The views, opinions, and content expressed herein do not necessarily reflect the views or policies of CSAT,
`SAMHSA, or HHS. No official support of or endorsement by CSAT, SAMHSA, or HHS for these opinions or for particular
`instruments, software, or resources is intended or should be inferred.
`Public Domain Notice: All materials appearing in this document except those taken directly from copyrighted sources are in
`the public domain and may be reproduced or copied without permission from SAMHSA or the authors. Citation of the source is
`appreciated. However, this publication may not be reproduced or distributed for a fee without the specific, written authorization
`of the Office of Communications, SAMHSA, HHS.
`Electronic Access and Copies of Publication: This publication may be ordered from SAMHSA’s Publications Ordering Web
`page at http://www.store.samhsa.gov. Or, please call SAMHSA at 1-877-SAMHSA-7 (1-877-726-4727) (English and Español).
`The document can be downloaded from the KAP Web site at http://www.kap.samhsa.gov.
`Recommended Citation: Center for Substance Abuse Treatment. “GHB: A Club Drug to Watch.” Substance Abuse Treatment
`Advisory, Volume 2, Issue 1, November, 2002.
`
`4
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`HHS Publication No. (SMA) 03-3766
`First printed 2002
`Revised 2011
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