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: n = 95 (numbers allocated to treatment and control conditions not reported; see note 1) Number completing: unclear Setting: outpatient; three sites; USA (New England) Inclusion criteria: For 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 three times the normal Ethnicity: AsPD subgroup: white (72.6%, n = 69); black (14.7%, n = 14); Hispanic (7. 4%, n = 7); native American (4.2%, n = 4); other (1.0%, 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 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) |
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Interventions | Two conditions: naltrexone / placebo (see note 2)
All participants received weekly Clinical Management / 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 |
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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); Alcohol craving (Obsessive Compulsive Drinking Scale) Leaving the study early: treatment retention |
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Notes |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | 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? | Unclear | 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? of participants |
Unclear | 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? of personnel |
Unclear | 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? of outcome assessors |
Unclear | 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 addressed? All outcomes |
Unclear | 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 |
Free of selective reporting? | Unclear | 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 |
Free of other bias? | Yes | 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 |