Table 1. Comparison of three randomized controlled trials that evaluated buprenorphine (BUP) or buprenorphine/naloxone (B/N) treatment for youth with opioid use disorders.
| Marsch et al. 2005 | Woody et al. 2008 | Marsch et al. 2016 | ||||
|---|---|---|---|---|---|---|
| Trial Location: Burlington Vermont Duration of study participation: 28 days | Trial Location: Multiple U.S. Sites Duration of study participation: 84 days | Trial Location: New York City Duration of study participation: 63 days | ||||
| Arm 1 | Arm 2 | Arm 1 | Arm 2 | Arm 1 | Arm 2 | |
| STUDY CHARACTERISTICS | ||||||
| Intervention | 28-day clonidine detoxification | 28-day BUP detoxification | 2-week B/N detoxification | 8-week stable B/N & 4-week BUP taper | 28-day B/N detoxification | 56-day B/N detoxification |
| Arm sample size (n) | 18 | 18 | 78 | 74 | 28 | 25 |
| DEMOGRAPHICS | ||||||
| Average age | 17.4 | 17.3 | 19.2 | 19.14 | 21 | 19.9 |
| Max age | 18 | 18 | 21 | 21 | 24 | 24 |
| Min age | 16 | 16 | 16 | 15 | 17 | 16 |
| % under 18 | 44% | 56% | 18% | 16% | 14% | 28% |
| Average age opioid use onset | 14.7 | 15 | - | - | 17 | 16 |
| % Male | 28% | 50% | 62% | 57% | 54% | 64% |
| % Caucasian | 94% | 100% | 72% | 76% | 81% | 70% |
| % with injection at study entry | 39% | 33% | 48% | 47% | 57% | 60% |
| Main Problem - Heroin | 50% | 55% | 53% | 57% | 86% | 76% |
| Main Problem - Rx Opioids | 50% | 45% | 32% | 36% | 14% | 24% |
| OTHER BASELINE SUBSTANCE USE/MENTAL ILLNESS | ||||||
| Substances | ||||||
| Alcohol | 18% (use disorder) | 17% (use disorder) | 40% (past 30-day) | 47% (past 30-day) | 25% (use disorder) | 28% (use disorder) |
| Nicotine | 29% (use disorder) | 50% (use disorder) | 88% (past 30-day) | 96% (past 30-day) | 71% (use disorder) | 32% (use disorder) |
| Cocaine | 3% (use disorder) | 17% (use disorder) | 47% (past 30-day) | 41% (past 30-day) | 25% (use disorder) | 28% (use disorder) |
| Amphetamine/Stimulant | 6% (use disorder) | 6% (use disorder) | 50% (past 30-day) | 43% (past 30-day) | 7% (use disorder) | 4% (use disorder) |
| Cannabis | 12% (use disorder) | 22% (use disorder) | 69% (past 30-day) | 64% (past 30-day) | 21% (use disorder) | 28% (use disorder) |
| Mental Illness | ||||||
| ADD/ADHD | 23% | 18% | - | - | 50% | 32% |
| Oppositional Defiant Disorder | 17% | 23% | - | - | 32% | 42% |
| Major Depression | 18% | 18% | - | - | 52% | 52% |
| Conduct Disorder | 6% | 13% | - | - | 29% | 33% |
| Mixed Anxiety/Depression | - | - | - | - | 71% | 60% |
| Manic Episode Disorder | - | - | - | - | 44% | 36% |
| BUP & B/N ADMINISTRATION PROCEDURES | ||||||
| Induction location | On site | On site | On site | On site | On site | On site |
| # hrs opioid abstinent at induction | 24 hrs | 24 hrs | 6 hrs | 6 hrs | 8-10 hrs | 8-10 hrs |
| First dose at induction | n/a | 6 or 8 mg | 2 mg | 2 mg | 6-8 mg (based on severity) | |
| Additional induction doses | n/a | None | 2-6 mg 1.5-2 hrs after first dose | 2-8 mg 1 hr after first dose | ||
| Withdrawal measurement | CINAS† | SOWS† | CINAS† | |||
| Take home doses permitted? | ||||||
| During induction | n/a | No | No | No | No | No |
| After induction | n/a | No | Yes (weekends) | Yes (weekends) | Yes: 2-3 × per wk | Yes: 2-3 × per wk |
| MAX BUP or B/N DOSE GIVEN IN ONE DAY* | ||||||
| 32 mg | n/a | - | - | 1% | - | - |
| 24 mg | n/a | - | - | 7% | - | - |
| 22 mg | n/a | - | - | 3% | - | - |
| 20 mg | n/a | - | 1% | 11% | - | - |
| 18 mg | n/a | - | - | 5% | - | - |
| 16 mg | n/a | - | 9% | 27% | 18% | 8% |
| 14 mg | n/a | - | 24% | 7% | - | - |
| 12 mg | n/a | - | 24% | 14% | 11% | 20% |
| 10 mg | n/a | - | 22% | 16% | - | - |
| 8 mg | n/a | 39% | 13% | 8% | 61% | 44% |
| 6 mg | n/a | 61% | 4% | 1% | 11% | 28% |
| 4 mg | n/a | - | 1% | - | - | - |
| 2 mg | n/a | - | 1% | - | - | - |
| OUTCOMES** | ||||||
| % Opioid abstinent | 32% (-) (utox) | 64% (-) (utox) | 49% (-) (utox) | 57% (-) (utox) | 17% (-) (utox) | 35% (-) (utox) |
| % Retained in treatment | 39% | 72% | 21% | 70% | 18% | 36% |
| Alcohol use*** | - | - | 24% (+) (slf rpt) | 22% (+) (slf rpt) | - | - |
| Cocaine use*** | 87% (-) (utox) (entire sample) | 26% (+) (slf rpt) | 16% (+) (slf rpt) | - | - | |
| Marijuana use*** | 29% (-) (utox) | 36% (-) (utox) | 50% (+) (slf rpt) | 50% (+) (slf rpt) | - | - |
| Benzodiazepine use*** | 93% (-) (utox) | 90% (-) (utox) | - | - | - | - |
| Risk behaviors (inject/sexual)*** | Reduced HIV risk behavior scores | 33% | 16% | - | - | |
| Initiated naltrexone treatment | 5% | 61% | - | - | - | - |
*
Woody et al. 2008 trial dose data were downloaded from https://datashare.nida.nih.gov/
**
“utox” = Urine toxicology; “(-)” indicates negative urine screen/abstinent; “(+)” indicates positive urine screen
***
During treatment
†
“SOWS” = Short Opiate Withdrawal Scale; “CINAS” = Clinical Institute Narcotic Assessment Scale