Sees and colleagues (2000) used a randomized controlled trial to compare outcomes of patients with opioid dependence treated with methadone maintenance treatment (MMT) to patients who received an alternative treatment (psychosocially enriched 180-day methadone-assisted [M–180] detoxification). More than 850 patients were initially screened to determine if they were eligible to participate in the study. Patients were eligible if they met the Diagnostic and Statistical Manual Mental Disorders, Third Edition, Revised (DSM–III–R) criteria for a diagnosis of opioid dependence and had an initial urine screening test result of positive for an opioid (other than methadone) and negative for methadone. Patients were excluded if they had a medical condition that contraindicated methadone treatment, had a psychiatric condition that would interfere with treatment, were enrolled in a substance abuse treatment program already, or were younger than 18 years. After the initial screening process, 179 patients were left for randomization.
Ninety-one patients were randomly selected to receive standard methadone maintenance (treatment group), and 88 received the 180-day methadone detoxification (comparison group). The treatment group was 57 percent male, and 46 percent white, 34 percent African American, 9 percent Hispanic, and 7 percent “other,” with an average age of 39.4 years. The comparison group was 60 percent male, and 52 percent white, 26 percent African American, 17 percent Hispanic, and 5 percent “other,” with an average age of 39.4 years. There were no significant differences between the two groups, except that comparison group members were more likely to be diagnosed as having an alcohol abuse or dependence disorder.
Study participants were assessed at baseline and every month for 12 months. Urine specimens were analyzed using an enzyme-multiplied immunoassay technique. The specimens were analyzed for the presence of cocaine, heroin, amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, and methadone.
The primary outcome measures of interests were opioid use and cocaine use. Opioid and cocaine use was coded as negative if the study participant reported no opioid or cocaine use in the last 30 days, and if the urine screening test result was negative for opioids other than methadone and negative for cocaine. The Addiction Severity Index (ASI) was also administered monthly to participants and assessed functioning in employment, drug use, alcohol use, legal, family, and psychiatric problem areas. The Risk of AIDS Behavior (or RAB) scale was also administered at 6 months and at 12 months to assess drug use and sexual behaviors that increase the risk for HIV infections over a 6-month period. The Treatment Services Review (TSR) was used to assess treatment services received in the past week. Treatment retention was measured as the number of days between study enrollment and the last day a participant received any psychosocial services.
In both groups, study participants were given an initial methadone dosage of 30 milligrams per day (mg/d), which was increased to 80 mg/d within the first 3 treatment weeks. The maximum methadone dosage was 100 mg/d, reached by day 44 of the study.
The study used an intent-to-treat analysis model that included all collected data in the analyses; complete-case-only analyses were not used. Retention in treatment was tested using Kaplan–Meier survival estimates and Wilcoxon signed rank test to compare groups. A treatment group by assessment generalized linear model was used to compare groups on other measures.
Gruber and colleagues (2008) used a randomized prospective trial to assess the benefits of transferring patients to 6 months of methadone maintenance, with either standard or minimal counseling, compared to keeping them in 21-day outpatient methadone detoxification. Patients were from a public hospital’s 21-day outpatient methadone detoxification program. They were eligible for the study if they had a DSM–III–R diagnosis of opioid dependence, were between the ages of 21 and 59 years, and expressed willingness to receive 6 months of methadone treatment.
There were 111 eligible participants who were randomized into one of three outpatient methadone treatment conditions:
· A usual care group consisting of 21-day methadone detoxification (n= 39)
· 6 months of methadone maintenance with minimal counseling (minimal MM), followed by a 6-week methadone detoxification (n= 35)
· 6 months of methadone maintenance with standard counseling (standard MM), followed by a 6-week methadone detoxification (n= 37)
The detoxification group was 74.4 percent male, and 40.5 percent white, 27 percent African American, 18.9 percent Hispanic, 8.1 percent Asian/Pacific Islander, and 5.4 percent Native American. The minimal MM and standard MM groups were 54 percent male, and 41.6 percent white, 32 percent African American, 20.8 percent Hispanic, 2.7 percent Asian/Pacific Islander, and 2.7 percent Native American. The only significant difference between the three groups was age: the standard MM group was younger (average age of 40.2 years) than the minimal MM group (42.6 years) and the detoxification group (43 years).
Methadone doses in each group ranged, from 60 mg to 90 mg.
The outcome measures were collected at baseline (before randomization) and at each of the seven monthly follow-ups. Monthly urine samples were analyzed for opiates, methadone, cocaine, amphetamines, barbiturates, benzodiazepines, and phencyclidine. Study participants were also asked to self-report the frequency and amount of heroin and cocaine use on each day of the past week. The ASI was administered to assess addiction problem severity in the past 30 days. The Beck Depression Inventory (or BDI) was used to assess symptoms of depression experienced in the past week. The TSR was used to assess treatment services received in the past week.
Outcomes were compared using parallel models that included treatment condition; assessment month (months 1–6, or months 1–8.5); and the interaction of condition-by-time. General estimating equations were used to adjust for the dependency inherent in repeated measures.