Table 3.
Summary of the principal outcomes of randomized clinical trials conducted in the National Institute on Drug Abuse Clinical Trials Network, testing the effectiveness of new treatment interventions among drug dependent patients in community-based drug treatment programs
| Study Number Author, Year |
Intervention Tested vs Control |
Principal Outcome Measures |
Intervention Outcome |
Control Outcome |
Effect Size(a) |
Site Effects |
|---|---|---|---|---|---|---|
|
Design 2a: [New intervention + TAU] vs TAU; New intervention is an add-on to TAU
| ||||||
| CTN 0006 Petry et al., 2005a |
Voucher incentives, 12 weeks vs TAU |
Continuous weeks abstinent: | 8.6 | 5.2 | 0.42*** | |
| ≥ 4 cont. abstinent weeks: In | 40% | 21% | 0.42*** | |||
| treatment at 12 weeks: | 49% | 35% | 0.29** | |||
|
| ||||||
| CTN 0007 Peirce et al., 2006 |
Voucher incentives, 12 weeks vs TAU |
Continuous weeks abstinent: | 5.5 | 2.3 | 0.55*** | ? site, site by treatment |
| ≥ 4 cont. abstinent weeks: | 24% | 9% | 0.42*** | |||
| In treatment at 12 weeks: | 67% | 65% | 0.04 | |||
|
| ||||||
| CTN 0009 Reid et al., 2008 |
Nicotine patch + group, 12 sessions vs TAU |
Nicotine abstinent week 13: | 6% | 0% | 0.47+ | |
| Cigarettes per day week 13: | 8.8 | 14.9 | 0.68*** | |||
|
| ||||||
|
Design 2b: [New Intervention + TAU] vs TAU; New intervention substitutes for a part of TAU
| ||||||
| CTN 0004 Carroll et al., 2006 |
MI during baseline, 1 session vs TAU |
Sessions attended month 1: | 5.0 | 4.0 | 0.24* | Site, site by treatment on skill, ?outcome |
| Enrolled at clinic month 1: | 84% | 75% | 0.23* | |||
| Days using primary substance: | 3.3 | 4.0 | 0.10 | |||
|
| ||||||
| CTN 0005 Ball et al., 2007 |
MET, 3 initial sessions vs TAU |
In treatment at 16 weeks: | 41% | 46% | -0.10 | Site*** on all outcomes |
| Days using primary substance: | ~0.2(b) | ~0.8 | Tx by time** |
|||
|
| ||||||
| CTN 0013 Winhusen et al., 2008 |
MET-Pregnancy, 3 initial sessions vs TAU |
% scheduled hours attended: | 62 | 62 | 0.00 | Site by Tx* on days to drop and drug pos |
| Days to dropout: | 48 | 54 | -0.17 | |||
| Drug positive urine month 1: | 25% | 28% | 0.07 | |||
|
| ||||||
| CTN 0021 Carroll et al., 2009 |
MET, 3 initial sessions vs TAU in Spanish |
In treatment at 12 weeks: | 57% | 52% | 0.10 | Site** on all outcomes |
| Days enrolled in treatment: | 46.1 | 42.0 | 0.15+ | |||
| % days abstinent prim. subst: | 94.7 | 92.2 | 0.16+ | |||
|
| ||||||
|
Design 3: [New Intervention + TAU] vs [Control Intervention + TAU]
| ||||||
| CTN 0001 Ling et al., 2005 |
Buprenorphine, 14 day taper vs clonidine |
In treatment and opioid negative urine on day 14: |
77% | 22% | 1.17*** | |
| Opioid withdrawal (COWS): | 3.8 | 7.4 | 1.35*** | |||
|
| ||||||
| CTN 0002 Ling et al., 2005 |
Buprenorphine, 14 day taper vs clonidine |
In treatment and opioid negative urine on day 14: |
29% 4.0 | 5% 5.1 | 0.67*** | |
| Opioid withdrawal (COWS): | 0.36** | |||||
|
| ||||||
| CTN 0003 Ling et al., 2009 |
Buprenorphine, 25 day taper vs 7 day taper |
Opioid neg urine post taper: | 30% | 44% | 0.29*** | |
| Opioid neg urine month 3: | 13% | 12% | 0.03 | |||
| Withdrawal (COWS) p taper: | 2.5 | 2.7 | 0.06 | |||
|
| ||||||
| CTN 0010 Woody et al., 2008 |
Buprenorphine × 3 months vs 14 day taper |
Opioid negative urine week 4: | 74% | 39% | 0.72*** | No site by Tx effects |
| Opioid negative urine week 8: | 77% | 46% | 0.65*** | |||
| In treatment at week 12: | 70% | 21% | 1.03*** | |||
|
| ||||||
| CTN 0011 Hubbard et al., 2007 |
Discharge planning + 4 phone follow-ups vs planning only |
≥ 1 outpatient visit self-report: | 67% | 67% | 0.00 | |
| ≥ 1 outpatient visit verified: (from program records) |
56% | 45% | 0.22+ | |||
|
| ||||||
| CTN 0015 Hien et al., 2009 |
Seeking Safety, vs Women’s Health Ed, 12 sessions |
PTSD symptoms, self-report (PSSR), months 3, 6, 12: |
30.0 | 32.0 | 0.14 | Site*** on both outcomes, no site by Tx |
| Abstinence, months 3, 6, 12: | 46% | 43% | 0.06 | |||
|
| ||||||
| CTN 0018 Calsyn et al., 2009 |
Safer sex skills, 5 sessions, vs 1 session HIV education |
90 day count of unprotected sexual occasions at month 6: |
16.0 | 19.0 | 0.17* (c) | Site entered as random effect |
|
| ||||||
| CTN 0019 Tross et al., 2008 |
Safer Sex Skills, 5 sessions, vs 1 session HIV Education |
90 day count of unprotected sexual occasions at month 6: |
14.0 | 24.1 | 0.42* (c) | Site entered as random effect |
|
| ||||||
|
Design 2/3 Hybrid, 3 Group Design: [New Intervention + TAU] vs [Control Intervention + TAU] vs TAU
| ||||||
| CTN 0017 Campbell et al., 2009 |
Therapeutic Alliance intervention (TA), 1 session, vs TAU |
Probability of outpatient treatment entry: |
0.46 | 0.31 | 0.22* | Site*** on outpatient Tx entry |
| Probability of 12-step entry: | 0.74 | 0.65 | 0.17 | |||
|
| ||||||
| CTN 0017 Campbell et al., 2009 |
TA, 1 session, vs HIV/HCV risk reduction, 2 sessions |
Probability of outpatient treatment entry: |
0.46 | 0.37 | 0.13 | Site*** on outpatient Tx entry |
| Probability of 12-step entry: | 0.74 | 0.63 | 0.21* | |||
Significance levels:
+
p < .10;
*
p < .05;
**
p < .01;
***
p < .001
(a)
For continuous measures the effect size estimate is Cohen’s d, the standardized difference between means; for dichotomous measures, the effect size estimate is Cohen’s h (difference between arcsine-transformed proportions); h and d are comparable.
(b)
In CTN 0005, for outcome of days using primary substance, interaction found “sleeper effect” with MET superior in weeks 5 to 16
(c)
In CTN 0018 and CTN 0019, treatment effects indicated by significant treatment by time interactions (p < .001)