Jeffrey J. Annon

Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience

In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16 mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.

Buprenorphine tapering schedule and illicit opioid use

AIMS To compare the effects of a short or long taper schedule after buprenorphine stabilization on participant outcomes as measured by opioid-free urine tests at the end of each taper period. DESIGN This multi-site study sponsored by Clinical Trials Network (CTN, a branch of the US National Institute on Drug Abuse) was conducted from 2003 to 2005 to compare two taper conditions (7 days and 28 days). Data were collected at weekly clinic visits to the end of the taper periods, and at 1-month and 3-month post-taper follow-up visits. SETTING Eleven out-patient treatment programs in 10 US cities. INTERVENTION Non-blinded dosing with Suboxone during the 1-month stabilization phase included 3 weeks of flexible dosing as determined appropriate by the study physicians. A fixed dose was required for the final week before beginning the taper phase. MEASUREMENTS The percentage of participants in each taper group providing urine samples free of illicit opioids at the end of the taper and at follow-up. FINDINGS At the end of the taper, 44% of the 7-day taper group (n = 255) provided opioid-free urine specimens compared to 30% of the 28-day taper group (n = 261; P = 0.0007). There were no differences at the 1-month and 3-month follow-ups (7-day = 18% and 12%; 28-day = 18% and 13%, 1 month and 3 months, respectively). CONCLUSION For individuals terminating buprenorphine pharmacotherapy for opioid dependence, there appears to be no advantage in prolonging the duration of taper.

HIV Risk Behaviors among Women in Methadone Maintenance Treatment

This article reports on the HIV risk behaviors of a sample of 158 women heroin addicts admitted into the Los Angeles Enhanced Methadone Maintenance Project. Risk behaviors for HIV were associated with age, lack of education, ethnicity, relationship with a drug user, HIV status, and higher scores on measures of illegal activity, suicidality, depression, polydrug use, and alcohol use. Significant reductions in number of male sex partners and needle-sharing partners were reported at follow-up, although frequency of condom use was unchanged. Methadone maintenance programs need to screen women for risk factors and assist them in developing new behavioral skills in order to implement a harm reduction approach to treatment.

Predictors of outcome for short-term medically supervised opioid withdrawal during a randomized, multicenter trial of buprenorphine-naloxone and clonidine in the NIDA clinical trials network drug and alcohol dependence

Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid-dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically supervised withdrawal study. Subjects were either inpatient or outpatient in community treatment settings; however not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes.

Ethnic Differences in HIV Risk Behaviors, Self-Perceptions, and Treatment Outcomes among Women in Methadone Maintenance Treatment

This study examined the HIV risk profiles of White, African-American, and Latina women enrolled in the UCLA Enhanced Methadone Maintenance Project, a NIDA-funded research demonstration project with the goal of reducing risk of HIV infection and/or transmission. Each group demonstrated distinct patterns associated with family relationships, sources of income, sexual and injection behaviors, and self-perceptions, although they were similar in their employment, drug use, mental health, and criminal behavior histories. In general, Latinas were more likely to report familial influences and to display evidence of low self-esteem and self-efficacy, inconsistent condom use, and high-risk injection behavior. White women reported the highest levels of regular condom use at follow-up; however, they were the least likely to report safer injection practices. African-American women expressed the highest levels self-esteem, yet they reported more alcohol use at intake and crack cocaine use both before and after treatment entry. They showed the greatest gains in adopting safer injection practices and were the least likely to report multiple sex partners after treatment entry. These findings can be used to improve the potential of methadone maintenance treatment for HIV risk reduction for women and to aid in developing culturally sensitive treatment protocols.

Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence.

AIMS To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence. DESIGN A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only). SETTING Three substance abuse treatment clinics: two in-patient, one out-patient. PARTICIPANTS Treatment-seeking, methamphetamine-dependent adults (n = 120). MEASUREMENTS Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial. FINDINGS No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events. CONCLUSIONS The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving.

Drug Use and Risk for HIV Among Women Arrestees in California

The rate of women entering the criminal justice system, particularly from drug-related crimes, is increasing. This study examined the characteristics and HIV risk behaviors of drug-using women arrestees in 13 California counties (N = 532). The injecting drug users (IDUs) (18%) were compared with the noninjecting drug users. The IDUs were older, more often White than African American, and were more likely to have a history of STDs, previous arrest, and polydrug use. Although the IDUs were at higher risk for HIV from their injection drug use and greater involvement in sex work, a substantial number of non-IDUs also engaged in high-risk sexual behaviors. Only a small percentage of the women sampled tested positive for HIV antibodies, however, the generally high-risk profile of this sample of drug-using women arrestees suggests that they would benefit from interventions that link them with needed treatment and services.

Characterization of Substance Abuse Patients Presenting for Treatment at a University Psychiatric Hospital in Cairo, Egypt

ObjectivesThis study was designed to assess the patterns and severity of drug and alcohol problems of a group of patients presenting for treatment at a substance abuse treatment program in Egypt. MethodsA total of 268 patients with drug/alcohol problems were interviewed at the Ain Shams Institute of Psychiatry in Cairo over a period of 1 year (2005 to 2006) using the Arabic version of the Addiction Severity Index, 5th edition. One hundred sixty patients were interviewed during the intake session and the other 108 were interviewed within the first week of their admission to the treatment program. ResultsIn the past 30 days before admission to the treatment program, 30% of the patients reported medical problems, 38% reported employment problems, 9% reported illegal activities, 62% reported serious conflicts with their families, 37% reported serious conflicts with other people, and 64% reported one or more psychiatric symptoms. The major drug problem was heroin for 52% of the patients, other opiates for 23%, and other drugs, including alcohol, for the remaining 25% of the patients. ConclusionsOpiates were the major drug problem for most of our patients, representing 75% of cases, whereas barbiturates, stimulants, hallucinogens, and inhalants were rarely found to be the major drug problem for patients. Injection was a significant problem for heroin users that needs to be addressed in treatment programs.

Inside the Black Box: Measuring Addiction Treatment Services and Their Relation to Outcomes

Abstract The adoption of performance-based management has been under consideration by addiction treatment funding agencies, and, recently, many state and county agencies have developed performance-based measurement/management systems in an attempt to improve their treatment system. This article describes one such effort in Los Angeles County, California. The Performance-Based Pilot Project linked treatment encounters (counseling sessions, drug testing, case management, and methadone dosing) with client outcomes (abstinence or reduced drug use at discharge) and longer lengths of stay in treatment. Eleven outpatient counseling programs and three narcotic treatment programs participated in the nine-month project. Results indicated that for both outpatient counseling and narcotic treatment programs, more sessions attended in the first 30 days was associated with better client outcomes and longer lengths of stay. Furthermore, in outpatient counseling programs, more group sessions during the first 30 days predicted abstinence or greater reductions in primary drug use; in narcotic treatment programs, more doses received during the first 30 days was correlated to longer treatment retention. This research implies that increasing the availability of counseling sessions for a clients first 30 days and engaging clients early is a promising area for program efforts to improve treatment outcomes and program performance.

Drum-assisted recovery therapy for native Americans (DARTNA)

Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is a substance abuse treatment intervention for American Indians/Alaska Natives (AI/ANs). This article provides results from 1) an initial pretest of DARTNA provided to 10 AI/AN patients with histories of substance use disorders, and 2) three subsequent focus groups conducted among AI/AN DARTNA pretest participants, substance abuse treatment providers, and the DARTNA Community Advisory Board. These research activities were conducted to finalize the DARTNA treatment manual; participants also provided helpful feedback which will assist toward this goal. Results suggest that DARTNA may be beneficial for AI/ANs with substance use problems.