Ralevski 2007.

Study characteristics
Methods	Design: placebo‐controlled parallel trial
Participants	Participants: treatment‐seeking adults with alcohol dependency and a current Axis I disorder (subgroup with AsPD) Sex: AsPD subgroup = 93 male, 2 female Age: AsPD subgroup mean = 44.2 (SD = 6.6) years Unit of allocation: individual participant Number randomised: AsPD subgroup = 95 (numbers allocated to treatment and control conditions not reported; see note 1) Number completing: unclear Setting: outpatient; 3 sites; USA (New England) Inclusion criteria: whole sample (see note 1) = treatment‐seeking; alcohol dependency with at least one other current Axis I disorder (DSM‐IV; SCID‐I); alcohol use within the past 30 days; stable dose of psychiatric medication for at least 2 weeks if on medication. Additionally for AsPD subgroup = presence of AsPD diagnosis (DSM‐IV; SCID‐II) Exclusion criteria: unstable psychotic symptoms; serious current psychiatric symptoms such as suicidal or homicidal ideation; current opiate dependence; contraindication to the use of naltrexone and disulfiram, including liver function tests greater than 3 times the normal Ethnicity: AsPD subgroup = 72.6% White (n = 69); 14.7% Black (n = 14); 7.4% Hispanic (n = 7); 4.2% native American (n = 4); 1% other (n = 1) Baseline characteristics: AsPD subgroup = all veterans; mean duration of alcohol use = 25.3 (SD = 8.9) years; mean number of drinking days in last 30 days = 14.3 (SD = 12.3) days; mean total number of drinks in last 30 days = 326.5 (SD =338.7); mean number of heavy drinking days in last 30 days = 13.4 (SD = 12.1); mean baseline on Alcohol Dependence Scale (ADS) score = 23.5 (SD = 7.8); any psychiatric medication (82.3%, n = 79); antidepressants (58.5%, n = 55); anxiolytics (6.3%, n = 6); mood stabilizers (40.6%, n = 39); antipsychotics (22.9%, n = 22); taking more than one medication (43.7%, n = 42)
Interventions	Two conditions (see note 2): naltrexone (oral, 50 mg/day) (number randomised not reported) placebo (number randomised not reported) All participants received weekly clinical management or compliance enhancement therapy focused on discussing negative consequences of drinking, relapse prevention, compliance monitoring and psychoeducation plus treatment as usual (rehabilitation with aftercare and supported housing options) Duration of intervention: 12 weeks Duration of trial: 12 weeks (no washout period) Length of follow‐up: participants were not followed up beyond the end of the intervention period Dose adjustment: no information
Outcomes	Primary outcomes Adverse events: Hopkins Symptom Checklist (self‐report) (described in Petrakis 2005 (p.1130, col 1) but no details reported for AsPD subgroup) Secondary outcomes Substance misuse: Alcohol use (Timeline Follow‐Back Interview (TLFB)); Alcohol craving (Obsessive Compulsive Drinking Scale (OCDS)) Leaving the study early: treatment retention Timing of outcome assessments TLFB and OCDS assessed weekly for 12 weeks
Notes	This study focuses on a subgroup of 95 participants with AsPD forming part of the sample of 254 participants randomised in a naltrexone/disulfiram trial for patients with alcohol dependence and comorbid psychiatric disorders (Petrakis 2005); numbers allocated to treatment and control conditions not reported by trial investigators The trial was conducted with two additional conditions, both open‐label: naltrexone (oral, 50 mg/day) + disulfiram (oral, 250 mg/day) and disulfiram (oral, 250 mg/day) + placebo. No information available on numbers randomised to these conditions Study funding: Veterans Affairs Merit Grant and the VA New England VISN I Mental Illness Research and Clinical Center (USA) Declaration of interests: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: No information provided. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Allocation concealment (selection bias)	Unclear risk	Comment: No information provided on how allocation sequence was concealed. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Blinding (performance bias and detection bias) of participants	Unclear risk	Comment: Trial investigators reported that naltrexone was given in a double‐blinded fashion, but provided no further information. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Blinding (performance bias and detection bias) of personnel	Unclear risk	Comment: Trial investigators reported that naltrexone was given in a double‐blinded fashion, but provided no further information. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Blinding (performance bias and detection bias) of outcome assessors	Unclear risk	Comment: Trial investigators reported that naltrexone was given in a double‐blinded fashion, but provided no further information. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: Incomplete outcome data arise from participants not completing the study and applies to all measured outcomes. Trial investigators provided no information on the numbers randomised to each condition, nor on the extent of missing data. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Selective reporting (reporting bias)	Unclear risk	Comment: A companion paper (Petrakis 2005) indicated that adverse events were measured weekly via the Hopkins Symptom Checklist, but these are not reported here or in that paper. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Other bias	Low risk	Comment: The study appeared free from other sources of potential bias, although the trial investigators acknowledge the possibility of bias arising from the confounding effects of Axis I disorders and their inability to test whether improvement in personality disorder symptoms were related to medication treatment.