Table 4.

Published RCTs of mindfulness or mindfulness meditation based interventions (MM) used for the treatment of substance use, misuse or disorders. In the Outcomes section, values presented in [square brackets] were calculated by the authors for this systematic review.

Feature	Study 1. Alterman et al. 2004 (36)	Study 2. Avants et al. 2005 (37)	Study 3. Margolin et al. 2006 (42)	Study 4. Hayes et al. 2004 (39)	Study 5. Gifford et al. 2004 (38)	Study 6. Linehan et al. 1999 (41)	Study 7. Linehan et al. 2002 (40)
Subjects	31 (17 F); mean age 36.5 yrs	29 (17 F); mean age 41.7 (28–51 yrs)	72 (47 F); mean age ~ 41 (21–56 yrs)	124 (63 F); mean age 42.2 (23–64 yrs); Axis II - 52%, anxiety and/or mood disorders ~ 42%	76 (45 F); mean age 43 (19–71 yrs)	28 F; mean age 30.4 (18–45 yrs); 50% depression, 38% PTSD	23 F; mean age 36.1 (18–45 yrs); anxiety and/or mood disorders 40–50%; past suicide or self- injury attempt 65%
Addictive disorder	PSR 4; SUDs, recovery house residents; alcohol + drugs 68%; prior Tx: 4.9 times for drug, 1.9 times for alcohol abuse.	PSR 4; opiate & cocaine dependent methadone maintenance out- patients; heroin use 17.1, cocaine use 16.5 yrs; majority with prior methadone Tx, and drug use in a prior month.	PSR 4; opiate dependent methadone maintenance out- patients; heroin use 17.7 yrs; cocaine use disorder 89%; prior methadone Tx 57%; majority used drugs in a prior month.	PSR 4; poly-SUDs; opiate dependent methadone maintenance out-patients, with other SUDs: 35% alcohol, 46% cocaine, 10% sedative dependent, who have continued drug use; prior residential or out-pt Tx: 6.3 times.	PSR 2; tobacco dependent community- recruited adults, with at least one past-year quit attempt; on average, smoked 21.4 cig/day, had 4 prior quit attempts (median success: 30 days) in the past 2 yrs.	PSR 4; BPD + SUDs; recruited from the clinic patients; 74% poly-SUDs, 58% cocaine, 52% alcohol; pre-study % days abstinent (alcohol, drugs): ~ 25–35%.	PSR 4; BPD + opiate dependence; recruited from variety of out-pt settings; 52% cocaine, 26% alcohol, 13% sedative dependent; prior methadone Tx: 83%.
MM group & MM intervention	N=18; MBSR- based, 8 wks: therapist-led group sessions (120 min/wk) & one retreat (7 hrs) + 30–45min meditation group meetings (4 times / wk).	N=11; 3-S (individual), 8 wks: therapist-led individual sessions (60 min/wk).	N=38; 3-S (two groups), 8 wks: • one educational session (60 min), AND • N=20; therapist- led individual sessions (60 min/wk), OR • N=18; therapist- led individual (60 min/wk) & group (60 min/wk) sessions.	N=42; ACT, 16 wks: therapist-led 32 individual (60 min) & 16 group (90 min) sessions.	N=33; ACT, 7 wks: therapist-led 7 individual (50 min/wk) & 7 group (90 min/wk) sessions.	N=12; DBT for SUDs, 52 wks: therapist-led individual (60 min/wk) & group (120 min/wk) sessions + skills coaching calls + optional 39-wk methadone or methylphenidate Tx for opiate or stimulant dependence.	N=11; DBT for SUDs, 52 wks: therapist-led individual (40–90 min/wk) & group (150 min/wk) sessions + optional individual coaching (30 min/wk) + diary cards.
Comparison group	N=13, SOC only.	N=18; 3-S (individual & group); 8 wks: therapist-led individual (60 min/wk) & group (60 min/wk) sessions.	N=34; ‘waitlist’ SOC only.	• N=44; ITSF, 16 wks: 32 individual (60 min) therapist or AA sponsor- led), + 16 group (90 min) therapist-led sessions. • N=38; SOC only.	N=43; NRT + medical Tx (physician-led): one 90 min group education session; then weekly clinic visits (physician visit as needed).	N=16; SOC only (subjects were referred to other clinics for SOC).	N=12; CVT + 12- Step, 52 wks: individual (40–90 min/wk) + NA group (120 min/wk) + optional 12-Step sponsor meetings.
Ancillary treatment (all groups)	SOC	One 60 min individual HIV educational session + SOC	SOC	SOC	None	None	ORLAAM (52 wks), physician-led medical Tx, weekly UTox for opiates during Tx; case management; PTSD Tx, crisis intervention, 12- Step.
Follow-up	0, 8, 22 wks	0, 8 wks	0, 8 wks	0, 8, 16, 42 wks	0, 7, 26, 52 wks	0, 16, 32, 52, 68 wks	0, 16, 32, 52, 68 wks
Retention (at the end of follow-up):	• MM (MBSR- based) 83%; • SOC 77%	• MM (3-S Individual) 64%; • MM (3-S Individual+Group) 89%	• MM (3-S) 82%; • SOC 88%	• MM (ACT) 43%; • ITSF 57%; • SOC 68% (differential retention: p<0.07)	• MM (ACT) 61%; • NRT 81% (differential retention: p=0.07)	• MM (DBT) 58%; • SOC 50%	• MM (DBT) 82%; • CVT+12-Step 83%
Outcome measures	Drug use (self- report, UTox); psychological health, problem level (ASI composite scores); meditation practice	Drug use (self- report, UTox); HIV risk behavior, spirituality, religious practices (surveys, reaction time task); Tx experiences.	Drug use (HIV risk behavior survey, with "yes/no" question on injection drug use or unprotected sex; UTox), HIV prevention motivation; spirituality, religious practices (surveys, reaction time task); Tx experiences.	Drug use (self-report, UTox); psychopathology; Tx satisfaction.	Tobacco use (self-report, exhaled CO); dependence, withdrawal symptoms, coping styles, psychological health; Working Alliance Inventory; Tx satisfaction.	Drug use (self- report, UTox); prior Tx, parasuicide history, the global adjustment and the global social adjustment, anger expression.	Drug use (self- report, UTox); parasuicide history, the global adjustment and the global social adjustment, Brief Symptom Inventory.
Substance use related outcomes (per ITT & PP analyses, at the end of follow-up, unless stated otherwise)	ITT: N/A; PP: • no differences between the groups (ES < 0.1); • compared to baseline, both groups decreased substance use.	ITT: N/A; PP: • no differences between the groups; • compared to baseline, the groups (combined into one sample) decreased heroin and cocaine use (p<0.05 [ES 0.5]) and HIV risk behavior (p=0.08 [ES 0.4]); • all but one subject reported positive 3-S effects on drug use, craving, motivation for abstinence and HIV prevention.	ITT: N/A; PP: • compared to SOC controls, fewer 3-S subjects injected drugs and/or had unsafe sex (53% vs. 23%, p<0.05 [ARR 30%, NNT 3.3]); • receipt of 3-S therapy was an independent protective factor against engaging in these behaviors (OR 8.9, p<0.05); • 3–S attendance was correlated to HIV risk behaviors (r= − 0.33, p<0.05; [ES 0.7]).	ITT: • no significant differences between the ACT, ITSF and SOC groups (no details provided); PP: • the ACT and ITSF groups, compared to SOC, had more ‘clean’ UTox for opiates (61%, 50%, 28%, p<0.05 [ACT vs. SOC: ARR 33%, NNT 3.0; ACT vs. ITSF: ARR 11%, NNT 9.1]) and all drugs (50%, 38%, 12%, p<0.05 [ACT vs. SOC: ARR 38%, NNT 2.6; ACT vs. ITSF: ARR 12%, NNT 8.3]); • the ACT group tended to more accurately report drug use than the ITSF group (p<0.1).	ITT: • no significant difference in quit rate between the ACT and NRT groups (21% vs. 9%, p>0.05 [ARR 12%, NNT 8.3]); PP: • ACT had a better quit rate than the NRT group (35% vs. 15%, p<0.05 [ARR 20%, NNT 5]); • quit status was predicted by change in acceptance skills in the ACT group, and change in acceptance skills mediated effects of ACT on smoking status (p<0.05).	ITT: • DBT group had a higher proportion of drug/alcohol abstinent days compared to SOC (0.94 vs. 0.58, p<0.05, ES 0.59); PP: • The above difference was significant (ES 1.0).	ITT: • at 52 wks, DBT group reduced opiate use compared to CVT group (p<0.05), however, this difference disappeared at 68 wks (positive UTox for opiates: 27% vs. 33%, p>0.05 [ARR 5%; NNT 22]); • during the 52-wk long Tx, the DBT group was more accurate in substance use reporting than CVT group (p<0.05). PP: N/A.
Other outcomes (per ITT & PP analyses, at the end of follow-up, unless stated otherwise)	ITT: N/A; PP: • the Addiction Severity Index medical composite score improved in the MM, but not SOC group (p<0.05, ES 0.195); • 47% MM subjects continued meditating (4 hrs during the prior month).	ITT: N/A; PP: • compared to baseline, 3-S subjects increased spiritual practices, and showed a cognitive shift from ‘addict’ to ‘spiritual’ self (p<0.05); • spirituality correlated to drug abstinence (r= 0.6, p<0.05 [ES 0.4]) and to decrease in HIV risk behavior (r= 0.67, p<0.05 [ES 0.45]).	ITT: N/A; PP: • compared to SOC, 3-S group increased spiritual practices and motivation for HIV prevention, and showed a cognitive shift from ‘addict’ to ‘spiritual qualities’ (p<0.05); • all 3-S subjects reported meditating (mean 25.7 min/day) and planned continuing it.	ITT: • no differences between the groups in psychological health scores or Tx satisfaction ratings; • compared to baseline, the groups improved on majority of psychological outcomes (p<0.05). PP: Results as above.	ITT: N/A; PP: • the ACT subjects endorsed better relationship with their providers than the NRT subjects (p<0.05); • Tx satisfaction ratings were comparable between the groups.	(unclear whether ITT or PP was used): • compared to SOC, the DBT group received more psychotherapy (p<0.05), and improved the global adjustment and global social adjustment scores (p<0.05).	ITT: • no differences between the groups in psychopathology or jail time; • compared to baseline, both groups improved the Brief Symptom Inventory scores and global adjustment ratings.
Adverse effects	Not mentioned	Not mentioned	Not mentioned	Not mentioned	Not mentioned	Not mentioned	Not mentioned
MQS / 17	8	8	11	12	13	13	14
CBS (ITT & PP analyses)	ITT: N/A PP: +2	ITT: N/A PP: −1	ITT: N/A PP: +2	ITT: −1 PP: +2	ITT: −1 PP: +2	ITT: +1 PP: +1	ITT: +1 PP: N/A
Comments	All subjects lived in the same recovery house.	The sample was randomized to individual or individual + group therapy, however, detailed results are reported as for pre-post one group.	After the initial randomization, the MM group was sub-randomized to individual (N=20) or individual + group therapy (N=18); in the final analysis, these subgroups were combined into one MM group.	3-arm RCT, with two "active" interventions (MM and ITSF) that were "matched" by subject involvement and therapy format (but not therapist contact time).	None	Low Tx completion rate, especially in the SOC group (DBT 55%, SOC 19% per ITT).	Two interventions were "matched" by subject involvement and therapy format (but not therapist contact time). One subject was randomized incorrectly, removed before the study onset and not analyzed (resulting in N=23). All drop- outs took place in the DBT group led by the only male therapist.

Values (presented in [square brackets]) calculated for the systematic review: ARR: Absolute Risk Reduction; CBS: Clinical Benefit Score; CES: Cumulative Evidence Score; ES: Effect Size (Cohen's d); MQS: Methodological Quality Score; NNT: Number Needed to Treat; PSS: Population Severity Score.

ACT: Acceptance Commitment Therapy; BPD: borderline personality disorder; CO: carbon monoxide; CVT: Comprehensive Validation Therapy; DBT: Dialectical Behavior Therapy; MM: mindfulness meditation; HIV: Human Immunodeficiency Virus; ITSF: Intensive Twelve Step Facilitation; ITT: intention to treat analysis; MBSR: Mindfulness-Based Stress Reduction; min: minutes; mos: months; NRT: Nicotine Replacement Therapy; ORLAAM: oral solution levomethadyl acetate, opiate agonist; PP: per protocol analysis; PTSD: post-traumatic stress disorder; 3-S: Spiritual Self Schema; SOC: "standard of care" therapy; SUDs: Substance Use Disorders; TSF: Twelve Step Facilitation; Tx: treatment; UTox: urine toxicology test; wks: weeks; yrs: years.