Table 1.
Clinical trials of potential anti-inflammatory treatments for substance use disorder.
| Clinical trial | Study design | SUDa | Participants | Dose/duration | Outcome measures |
|---|---|---|---|---|---|
| Ibudilast | |||||
| NCT03341078 Not yet recruiting |
Phase II: Double-blind, randomized, placebo controlled, parallel assignment | MA | Use disorder N = 65 | 20 mg bid (2 wks) 50 mg bid (4 wks) |
Neuroinflammation (PET); Monetary Incentive Delay Task and functional connectivity (fMRI); Cognitive function, Craving and MA use |
| NCT02025998 Completed |
Phase I: Double-blind, randomized, placebo controlled, cross-over | Alcohol | Dependence/abuse N= 24 | 50 mg bid (1 wk) | Alcohol effects; Alcohol urge; Cue & stress-induced craving; Differential emotion |
| NCT03489850 Not yet recruiting |
Phase II: Double-blind, randomized, placebo controlled, parallel assignment | Alcohol | In treatment/seeking N= 50 | 20 mg (2 d) 50 mg bid (12 d) | Alcohol-related negative reinforcement; Cue-reactivity (fMRI); Withdrawal-related dysphoria |
| NCT01860807 Not yet recruiting |
Phase II: Double-blind, randomized, placebo controlled, cross-over | MA | Treatment seeking N = 140 | 50 mg bid (12 wks) | MA use; Treatment retention |
| NCT01860807 Completed |
Phase I: Double-blind, randomized, placebo controlled, crossover | MA | Dependence N = 11 | 20 mg (1 wk) 50 mg bid (1 wk) | Safety and tolerability with MA; Craving and drug effects; Discounting tasks |
| Minocycline | |||||
| NCT03244592 Not yet recruiting |
Phase I & II: Double-blind, randomized, placebo controlled, parallel assignment | Alcohol | Dependence/abuse N= 32 | 200 mg (4 wks) | Neuroinflammation (PET); Cue-induced craving; Alcohol use; Cognitive function |
| NCT02541500 | Phase III: Open label, single group assignment | Opioid Stimulant | Dependence N = 40 | 200 mg (4 mos) | Stimulant use; Treatment retention; HIV-risk (sex and drug behaviors); Neuropsychological function |
| NCT02359006 Completed |
Double-blind, randomized, placebo controlled, crossover | Opioid | Current methadone maintenance N = 55 | 200 mg (15 d) | Pain sensitivity; Withdrawal symptoms; Cognitive Performance |
| NCT02187211 Recruiting |
Phase I: Double-blind, randomized, placebo controlled, cross-over | Alcohol | Heavy social drinkers N= 60 | 200 or 400 mg (10 d) | Effects of alcohol |
| Pioglitazone | |||||
| NCT01395784 Completed |
Phase II: Non-randomized | Opioid | Prescription abuse N= 32 | 15 then 45 mg(9 wks) | Subjective drug effects (VAS) Analgesic Response (Cold pressor test) |
| NCT01517165 Completed |
Phase I: Randomized, Parallel Assignment | Opioid | In treatment with buprenorphine N = 24 | mg not specified (13 wks) | Abstinence without severe withdrawal; Proportions of negative urine toxicology and need for adjuct medication |
| NCT01395797 Completed |
Phase I & II: Randomized, Parallel Assignment | Opioid Nicotine | Dependence to heroin or nicotine N = 82 | 0, 15 mg or 45 mg (2 wks) | Persistence of responding (Drug Break Point) Subjective drug effects (VAS) |
| NCT01631630 Completed |
Phase II: Randomized, Parallel Assignment | Alcohol | Use disorder N = 16 | 45 mg (2 wks) | Alcohol urge; Anxiety, Depression scales; Craving |
| NCT02774343 Completed |
Phase I & II: Randomized, Parallel Assignment | Cocaine | Cocaine dependent N= 30 | 30 then 45 mg (12 wks) | White-matter Integrity (DTI); Obsessive Compulsive Drug Use Scale; Cue reactivity; cocaine use and craving |
| NCT03060772 Recruiting |
Phase II: Randomized, Parallel Assignment | Alcohol | Use disorder N = 36 | 30 mg (4 wks) | Phagocytic Index; NADPH oxidase; Alveolar macrophage oxidative stress; GSH/GSSG; Cys/CySS redox potential |
a
Studies of opioid use disorder are included in the table, although the role of neuroinflammation in opioid addiction was not a focus of this review. Recent, comprehensive reviews on glia and opioids are available (Bachtell et al., 2017; Kadhim et al., 2018). Abbreviations: DTI, diffusion tension imaging; MA, methamphetamine; SUD, substance use disorder; VAS, visual analogue scale.