A randomized controlled trial of interim methadone maintenance. A randomized clinical trial of methadone maintenance for prisoners: results at 1-month post-release. Methadone maintenance as HIV risk reduction with street-recruited injecting drug users. Heroin-assisted treatment for opioid dependence: randomised controlled trial. Evaluation of heroin maintenance in controlled trial. Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence: a randomized controlled trial. Outcomes after methadone maintenance and methadone reduction treatments: two-year follow-up results from the National Treatment Outcome Research Study. A controlled trial of methadone maintenance in a population of intravenous drug users in Bangkok: implications for prevention of HIV. A randomized trial of 6-month methadone maintenance with standard or minimal counseling versus 21-day methadone detoxification.
Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry.
                To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior.
                Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control.
                A methadone treatment program in Baltimore.
                A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment.
                Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs.
                Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment).
                Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (P<.001). Overall, in the past 30 days at follow-up, interim participants reported significantly fewer days of heroin use (P<.001), had a significant reduction in heroin-positive drug test results (P<.001), reported spending less money on drugs (P<.001), and received less illegal income (P<.02) than the waiting list participants.
                Interim methadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program. Despite its effectiveness, methadone maintenance is rarely provided in American correctional facilities. This study is the first randomized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction.
                A three-group randomized controlled trial was conducted between September 2003 and June 2005. Two hundred eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study. Participants were randomly assigned to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n=70); counseling+transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n=70); and counseling+methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n=71).
                Two hundred participants were located for follow-up interviews and included in the current analysis. The percentages of participants in each condition that entered community-based treatment were, respectively, counseling only 7.8%, counseling+transfer 50.0%, and counseling+methadone 68.6%, p<.05. All pairwise comparisons were statistically significant (all ps<.05). The percentage of participants in each condition that tested positive for opioids at 1-month post-release were, respectively, counseling only 62.9%, counseling+transfer 41.0%, and counseling+methadone 27.6%, p<.05, with the counseling only group significantly more likely to test positive than the counseling+methadone group.
                Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories. To compare changes in HIV risk behaviors between street-recruited opiate injectors who entered and remained in methadone maintenance treatment and those who did not.
                Three hundred sixteen participants were interviewed at baseline, received outreach interventions, and were interviewed again 6 months later.
                Significant (p <.001) reductions in HIV-related risk behaviors, including frequency of injecting, injecting with used (dirty) needles, and sharing injection paraphernalia, were demonstrated. Participants (31%) who entered and remained in methadone maintenance treatment for at least 90 days before follow-up showed a significantly greater reduction in heroin injections than those who did not. They did not show a greater reduction in using dirty needles or sharing other injection paraphernalia.
                These findings suggest that although methadone maintenance may reduce injection frequency, it does not reduce other HIV-related risk behaviors above and beyond what can be accomplished through outreach interventions. Treatment facilities and outreach intervention programs should collaborate to provide a comprehensive approach to reducing HIV risk behaviors among drug injectors both in and out of drug treatment. Heroin-assisted treatment has been found to be effective for people with severe opioid dependence who are not interested in or do poorly on methadone maintenance.
                To study heroin-assisted treatment in people on methadone who continue intravenous heroin and in those who are heroin dependent but currently not in treatment.
                In an open-label multicentre randomised controlled trial, 1015 people with heroin dependence received a variable dose of injectable heroin (n=515) or oral methadone (n=500) for 12 months. Two response criteria, improvement of physical and/or mental health and decrease in illicit drug use, were evaluated in an intent-to-treat analysis.
                Retention was higher in the heroin (67.2%) than in the methadone group (40.0%) and the heroin group showed a significantly greater response on both primary outcome measures. More serious adverse events were found in the heroin group, and were mainly associated with intravenous use.
                Heroin-assisted treatment is more effective for people with opioid dependence who continue intravenous heroin while on methadone maintenance or who are not enrolled in treatment. Despite a higher risk, it should be considered for treatment resistance under medical supervision. Ninety-six confirmed heroin addicts requesting a heroin maintenance prescription were randomly allocated to treatment with injectable heroin or oral methadone. Progress was monitored throughout the next 12 months by research workers operating independently of the clinic. Heroin can be seen as maintaining the status quo, with the majority continuing to inject heroin regularly and to supplement their maintenance prescription from other sources; it was associated with a continuing intermediate level of involvement with the drug subculture and criminal activity. Refusal to prescribe heroin while offering oral methadone constituted a more confrontational response and resulted in a higher abstinence rate, but also a greater dependence on illegal sources of drugs for these who continued to inject. Those offered oral methadone tended to polarize toward high or low categories of illegal drug use and involvement with the drug subculture, and were more likely to be arrested during the 12-month follow-up. There was no difference between the two groups in terms of employment, health, or consumption of nonopiate drugs. Refusal to prescribe heroin resulted in a significantly greater drop out from regular treatment. Despite evidence that methadone maintenance treatment (MMT) is effective for opioid dependence, it remains a controversial therapy because of its indefinite provision of a dependence-producing medication.
                To compare outcomes of patients with opioid dependence treated with MMT vs an alternative treatment, psychosocially enriched 180-day methadone-assisted detoxification.
                Randomized controlled trial conducted from May 1995 to April 1999.
                Research clinic in an established drug treatment service.
                Of 858 volunteers screened, 179 adults with diagnosed opioid dependence were randomized into the study; 154 completed 12 weeks of follow-up.
                Patients were randomized to MMT (n = 91), which required 2 hours of psychosocial therapy per week during the first 6 months; or detoxification (n = 88), which required 3 hours of psychosocial therapy per week, 14 education sessions, and 1 hour of cocaine group therapy, if appropriate, for 6 months, and 6 months of (nonmethadone) aftercare services.
                Treatment retention, heroin and cocaine abstinence (by self-report and monthly urinalysis), human immunodeficiency virus (HIV) risk behaviors (Risk of AIDS Behavior scale score), and function in 5 problem areas: employment, family, psychiatric, legal, and alcohol use (Addiction Severity Index), compared by intervention group.
                Methadone maintenance therapy resulted in greater treatment retention (median, 438.5 vs 174.0 days) and lower heroin use rates than did detoxification. Cocaine use was more closely related to study dropout in detoxification than in MMT. Methadone maintenance therapy resulted in a lower rate of drug-related (mean [SD] at 12 months, 2.17 [3.88] vs 3.73 [6.86]) but not sex-related HIV risk behaviors and in a lower severity score for legal status (mean [SD] at 12 months, 0.05 [0.13] vs 0.13 [0.19]). There were no differences between groups in employment or family functioning or alcohol use. In both groups, monthly heroin use rates were 50% or greater, but days of use per month dropped markedly from baseline.
                Our results confirm the usefulness of MMT in reducing heroin use and HIV risk behaviors. Illicit opioid use continued in both groups, but frequency was reduced. Results do not provide support for diverting resources from MMT into long-term detoxification. This paper provides a detailed analysis of the 2-year outcomes for 351 drug misusers allocated on an intention-to-treat basis to methadone maintenance or methadone reduction treatments. Both groups showed substantial reductions in their use of illicit drugs and in other outcome areas. However, whereas most methadone maintenance patients received maintenance, only about one third of those allocated to methadone reduction received methadone reduction, and many actually received a form of methadone maintenance. Reduction patients were more likely to receive low doses of methadone, and were less likely to remain in treatment. For maintenance patients, higher doses and retention in treatment were both associated with improvements in illicit heroin use at 2 years. For the reduction patients, the more rapidly the methadone was reduced, the worse the heroin use outcomes. For patients in both treatment conditions, reductions in heroin use were associated with improvements in other outcome areas. The more severely dependent patients showed better outcomes in methadone maintenance. Methadone reduction treatment processes were associated with poor outcomes, and many patients who were allocated to methadone reduction treatment did not receive reduction treatment as intended. This calls into question the appropriateness of either the initial treatment planning process or the treatment delivery process, or both. A clearer distinction should be made between methadone maintenance and methadone reduction. Treatment goals should be made explicit both to the patient and to the clinical staff at the start of treatment. We suggest the need for a reappraisal of the goals and procedures of methadone reduction treatment. This study represents the first controlled trial of methadone maintenance and 45-day methadone detoxification in Thailand. We randomly assigned 240 male heroin addicts with at least six prior detoxification treatment episodes to 45-day detoxification or to methadone maintenance treatment conditions. We found that methadone maintenance clients were more likely to complete 45 days of treatment (p less than .00001), were less likely to have used heroin during treatment (p less than .0002), and were less likely to have used heroin on the 45th day of treatment (p less than .000007). These findings are consistent with the results of other studies in the United States, and we conclude that methadone maintenance could be a significant adjunct to AIDS prevention efforts for intravenous drug users in Thailand. Important questions remain regarding the necessary duration and intensity for methadone treatment to be effective.
                As part of a clinical trial of tuberculosis chemoprophylaxis [Batki, S.L., Gruber, V.A., Bradley, J.M., Bradley, M., Delucchi, K., 2002. A controlled trial of methadone treatment combined with directly observed isoniazid for tuberculosis prevention in injection drug users. Drug Alcohol Depend. 66 283-293. doi:10.1016/S0376-8716(01)00208-3], patients with opioid dependence were recruited from an outpatient 21-day methadone detoxification program and were randomly assigned to one of three treatment conditions: (1) continuation in 21-day methadone detoxification; (2) transfer to 6-month methadone maintenance with only minimal counseling; or (3) transfer to 6-month methadone maintenance with standard twice monthly counseling and as-needed social work and psychiatric services. Both the 6-month maintenance treatments were followed by 1.5 months of detoxification. Urine drug tests and self-report measures were collected at baseline, months 1-6, and month 8.5.
                Compared to 21-day methadone detoxification, 6-month methadone maintenance with either minimal or standard counseling resulted in fewer opiate positive urine tests and days of self-reported heroin and alcohol use. There was no change in cocaine use or other outcome measures. The increased counseling available in the standard counseling condition did not appear to reduce heroin use further than the minimal counseling condition, in contrast to the effect found for more structured counseling in long-term methadone maintenance (McLellan et al., 1993).
                Six months of methadone maintenance, even with minimal counseling, reduces heroin and alcohol use more than 21-day methadone detoxification.
Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality.