Robert F. Forman

Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.

CONTEXT The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. OBJECTIVE To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. DESIGN, SETTING, AND PATIENTS Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). INTERVENTIONS Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. MAIN OUTCOME MEASURE Opioid-positive urine test result at weeks 4, 8, and 12. RESULTS The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. CONCLUSIONS Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00078130.

Staff beliefs about addiction treatment

In 1999, the National Institute on Drug Abuse established a researcher/provider partnership designed to test the effectiveness of research-based innovations in community-based treatment settings and facilitate the transfer of those innovations throughout the national treatment system. As a preliminary step in developing their local Clinical Trials Network, researchers and treatment providers within the Delaware Valley Node surveyed 317 staff members concerning their beliefs about addiction treatment. More than 80% of respondents supported increased use of research-based innovations, 12-step/traditional approaches, and spirituality in addiction treatment, while only 39% and 34%, respectively, endorsed the increased use of naltrexone and methadone maintenance. Also, 35% of respondents indicated that confrontation should be used more, and 46% agreed with discharging noncompliant patients. Individuals with more formal training tended to be less supportive of confrontation and more supportive of the increased use of medications. Implications for the clinical trials and technology transfer are discussed.

Long-Term Opioid Blockade and Hedonic Response: Preliminary Data from Two Open-Label Extension Studies with Extended-Release Naltrexone

The emergence of extended-release naltrexone (XR-NTX) raises the opportunity to explore the role of endorphin blockade on hedonic response during long-term alcohol dependence treatment. A hedonic survey was administered to 74 alcohol dependent patients treated for an average of 3.5 years with nearly continuous month-long intramuscular XR-NTX. The paper-and-pencil, one-time survey asked patients about the degree of pleasure they experienced in the past 90 days with drinking alcohol, sex, exercise and other daily activities. The data revealed lower pleasure ratings for alcohol than for sex, exercise and 10 other common activities. Mean responses to drinking alcohol and gambling were significantly lower than to listening to music, sex, reading, being with friends, eating good food, eating spicy food, and playing video/card games. This effect was independent of XR-NTX dose or duration. Although this exploratory study lacked baseline data, a comparison group or control for the impact of patient discontinuation, the data indicate the feasibility of examining long-term hedonic response in recovery. The differential hedonic ratings suggest that, in patients who persist with long-term continuous therapy, XR-NTX may selectively inhibit the pleasure associated with drinking alcohol, compared to a variety of other activities. 

Online Illegal Drug Use Information: An Exploratory Analysis of Drug-Related Website Viewing by Adolescents

Given the uncertain effects of antidrug media campaigns, and the ease of finding online illegal drug information, research is needed on the Internet role in disseminating drug information to youths. This exploratory study analyzes National Survey of Parents and Youth (NSPY) data on drug website viewing among 12–18 year olds (N = 7,145). Approximately 10.4% reported drug-related website exposure: 5.4% viewed only websites that communicated how to avoid drugs or bad things about drugs (antidrug websites); 1.7% only viewed websites that communicated how to use drugs and good things about drugs (prodrug websites); and 3.2% viewed both types of websites. The low rates of viewing antidrug websites occurred despite efforts in the National Youth Antidrug Media Campaign (NYAMC) to encourage youths to visit such websites. Prodrug website viewers had used inhalants and been offered marijuana, perceived little risk in trying marijuana, intended to use marijuana, had close friends who used drugs, reported low parental monitoring, and had been exposed to antidrug media messages. Viewing antidrug websites was related to gender, income, likelihood of using marijuana in the next 12 months, having close friends who use drugs and talking to friends about avoiding drugs, parental monitoring, and drug prevention exposure. Prior prevention exposure increased drug website viewing overall, perhaps by increasing general curiosity about drugs. Because adolescents increasingly seek health information online, research is needed on how they use the Internet as a drug information source, the temporal relationships of prevention exposure and drug website viewing, and the effects of viewing prodrug websites on drug risk.

Nonprescription steroids on the Internet.

This study evaluated the degree to which anabolic-androgenic steroids are proffered for sale over the Internet and how they are characterized on popular Web sites. Searches for specific steroid product labels (e.g., Dianabol) between March 2006 and June 2006 revealed that approximately half of the Web sites advocated their “safe” use, and roughly one third offered to sell them without prescriptions. The Web sites frequently presented misinformation about steroids and minimized their dangers. Less than 5% of the Web sites presented accurate health risk information about steroids or provided information to abusers seeking to discontinue their steroid use. Implications for education, prevention, treatment, and policy are discussed.

The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients

A post hoc analysis examined the effect of extended-release naltrexone (XR-NTX) treatment combined with psychosocial support on alcohol consumption during holiday and nonholiday periods in a cohort of alcohol-dependent patients who had maintained at least 4 days of continuous abstinence before receiving their first treatment. Three parameters of drinking behavior were examined: percentage of drinking days, percentage of heavy drinking days, and the number of drinks per day. Patients receiving XR-NTX 380 mg reported significantly lower median percentages of drinking days, heavy drinking days, and the number of drinks per day compared with the placebo group. Patients treated with XR-NTX 190 mg reported similar results overall. The results suggest that treatment with XR-NTX 380 mg in combination with psychosocial intervention leads to significant reductions in alcohol consumption, with some measures indicating abstinence in alcohol-dependent patients with initial abstinence during holiday periods.

Efficacy of Extended-Release Naltrexone in Patients with Relatively Higher Severity of Alcohol Dependence

BACKGROUND Because some literature reviews have suggested that naltrexones benefit may be limited to less-severe alcohol dependence, and exclusively to reduction in heavy drinking rather than abstinence, we examined the efficacy of once per month, injectable extended-release naltrexone (XR-NTX 380 mg) in patients with relatively higher severity alcohol dependence. METHODS Post hoc analyses examined data from a multicenter, placebo-controlled, 24-week randomized trial of XR-NTX for alcohol dependence (N = 624). We analyzed treatment effects in alcohol-dependent patients who had higher baseline severity, as measured by: (i) the Alcohol Dependence Scale (ADS) or (ii) having been medically detoxified in the week before randomization. Efficacy was also examined via the relationship between pretreatment severity indices and reporting at least 4 days of lead-in abstinence prior to treatment-a major predictor of good outcome in the original study. RESULTS Higher severity alcohol-dependent patients, defined by the ADS, when receiving XR-NTX 380 mg (n = 50) compared with placebo (n = 47), had significantly fewer heavy-drinking days in-trial (hazard ratio=0.583; p = 0.0049) and showed an average reduction of 37.3% in heavy-drinking days compared with 27.4% for placebo-treated patients (p = 0.039). Among those who had a detoxification just prior to randomization, these reductions were 48.9% (XR-NTX 380 mg; n = 11) and 30.9% (placebo; n = 15) (p = 0.004). Subjects with at least 4 days of pretreatment abstinence (n = 82) versus those without (n = 542) had significantly higher pretreatment ADS scores (p = 0.002) and were more likely to require detoxification prior to randomization (p < 0.001). Patients with lead-in abstinence experienced significantly better maintenance of initial and 6-month abstinence. CONCLUSIONS These secondary analyses support the efficacy of XR-NTX 380 mg in relatively higher severity alcohol dependence for both reduction in heavy drinking and maintenance of abstinence, with implications for the role of adherence pharmacotherapy.

Implementing Evidence-Based Practices in Community Treatment Programs: Initial Feasibility of a Counselor “Toolkit”

ABSTRACT Community substance abuse treatment programs face many barriers to adopting “evidence-based” therapies. Training budgets are inadequate to permit acquisition of complex skills, there is little clinical supervision available, and almost all counseling is done in group sessions. The authors adopted an approach widely used in the teaching field—developing a resource “toolkit” for a specific topic, in this case, a Decisional Balance exercise often used in the evidence-based treatment approach of Motivational Interviewing. This trial toolkit was comprised of a DVD (televised during group to illustrate the clinical concept), a laminated counselor guide (to provide guidance and talking points for the counselor during group), and some worksheets and wallet cards for patients to retain key points (see Table 1). A feasibility trial assessed the acceptability, and sustainability of the “Decisional Balance” concept toolkit among 26 counselors and 210 of their patients, from 6 community-based substance abuse treatment programs. The great majority of patients (97%) and all counselors (100%) reported they were satisfied with the toolkit session; 84% of patients said they would like more groups like the toolkit session. Almost all counselors (96%) were still using at least one component of the toolkit 3 months after their initial exposure with no prompting. The toolkit curriculum–based approach may be a viable and attractive way of translating core concepts from sophisticated evidence-based therapies into use by counselors within contemporary, community-based treatment programs with minimal training.

Availability of websites offering to sell psilocybin spores and psilocybin.

Abstract This study assesses the availability of websites offering to sell psilocybin spores and psilocybin, a powerful hallucinogen contained in Psilocybe mushrooms. Over a 25-month period beginning in March 2003, eight searches were conducted in Google using the term “psilocybin spores.” In each search the first l00 nonsponsored links obtained were scored by two independent raters according to standardized criteria to determine whether they offered to sell psilocybin or psilocybin spores. No attempts were made to procure the products offered for sale in order to ascertain whether the marketed psilocybin was in fact “genuine” or “counterfeit.” Of the 800 links examined, 58% led to websites offering to sell psilocybin spores. Additionally, evidence that whole Psilocybe mushrooms are offered for sale online was obtained. Psilocybin and psilocybin spores were found to be widely available for sale over the Internet. Online purchase of psilocybin may facilitate illicit use of this potent psychoactive substance. Additional studies are needed to assess whether websites offering to sell psilocybin and psilocybin spores actually deliver their products as advertised.