Evidence Table 10: Serotonergic agents study designs [Evidence Tables]

Author, yearStudy design and blindingAlcohol dependence diagnosis and diagnostic instrumentSeverity assessmentDetoxifiedAbstinence periodDrug interventionCo-interventionLength of active trtInitial/end study population (n)Percent males initiallyMean age (SD) initiallyRaceCo-morbidityOther SACompliance measuresOutcome measuresRelapse definitionCraving measure
Gerra G, Caccavari R, Delsignore R, et al. (1992) CX-RDSM-III-R Instrument NANANANAPlacebo comparable to int grp

Int grp 1:
Fluoxetine: 40 mg/day
Weekly meetings4 wks for each treatment28/NA64.3 %43.5 (NA)NANoneNoNA- unspecified self-report
- proxy
NAFour 5-pt scales for interest, desire, liking, & intoxication
Gorelick DA, Paredes A (1992) CT-N-DBDSM-III Instrument NANANANAPlacebo comparable to int grps

Int grp 1:
fluoxetine: 80 mg/day (max)
None4 wksPlacebo: 10/7

Int grp 1: 10/10
100 %Placebo: 47.1 (9.8)

Int grp 1: 38.7 (9.7)
Placebo: 90 % (W)
10 % (H)

Int grp 1: 70 % (W)
30 % (B)
NoneNoDirect supervision in all groups- volume of alcohol consumedNA100 mm VAS
Kranzler HR, Del Boca F, Korner P, et al. (1993) CT-R-DBDSM-III-R by structured interview with individualLast 6 mos of drinking quexNANAPlacebo comparable to int grps

Int grp 1:
Fluvoxamine: 200 mg/day
Individual counseling for all groups12 wksPlacebo: 9/8

Int grp 1: 10/2
Placebo: 100 %

Int grp 1: 90 %
Placebo: 40.1 (10.3)

Int grp 1: 45.7 (11.4)
NANoneNoNone- TLFB
- last 6 months of drinking quex
NANot measured
Sellers EM, Toneatto T, Romach MK, et al. (1994) CT-R-DBDSM-III-R by structured interview with individualADSNANAPlacebo comparable to int grps

Int grp 1:
Ondansetron: 0.5 mg/day

Int grp 2:
Ondansetron: 4.0 mg/day
Individual counseling6 wksPlacebo: 23/17

Int grp 1: 23/18

Int grp 2: 25/21
100 %43.6 (9.7)99 % (W)NoneNoUrine marker and pill count for all grps- TLFB
- situational confidence quex
- tobacco and caffeine consumption form
- multiple adjective check list
- goal setting
- inventory of drinking situations
- adverse events enquiry
- daily log book
NA11-pt VAS
Kranzler HR, Burleson JA, Korner P, et al. (1995) Kranzler HR, Burleson JA, Brown J, et al.(1996) CT-R-DBDSM-III-R by structured interview with individualMAST & DACNA7 daysPlacebo comparable to int grps

Int grp 1:
Fluoxetine: 60 mg/day (max)
Group or individual counseling12 wksPlacebo: 50/49

Int grp 1: 51/46
80 %40.1 (8.6)95 % (W)DepressionYesUrine marker >3 urine tests w/riboflavin for all groups- self-report quex
- TLFB
- MAST
- proxy
NANA
Janiri L, Gobbi G, Mannelli P, et al. (1996) CT-R-DBDSM-III-R Instrument NA66 % severe but assessment method not specifiedYes >7 daysPlacebo comparable to int grps

Int grp 1:
Fluoxetine: 20 mg/day
AA and individual counseling encouraged8 wksPlacebo: 29/16

Int grp 1: 21/17
Placebo: 83 %

Int grp 1: 76 %
Placebo: 45.0 (15.0)

Int grp 1: 45.9 (21.1)
NAAxis I and II psychiatric disordersNoNA- structured interview with individual
- proxy
Continuous drinking

Drinking >3 days with daily consumption higher than 50 g
10 cm VAS
Kabel DI, Petty F (1996) CT-N-DBDSM-III-R by structured interview with individualMAST and DACYesNAPlacebo comparable to int grps

Int grp 1:
Fluoxetine: 60 mg/day (max)
AA encouraged12 wksPlacebo: 13/10

Int grp 1: 15/9
100 %46.8 (9.1)54 % (W)
36 % (B)
10 % (O)
NoneYesSelf-report for all grps- alcohol research quex
- TLFB
- proxy
>5 drinks/occ

>5 days/wk

- breath alcohol test
Quex on drinking urges
Malec E, Malec T, Gagne MA, et al. (1996) CT-R-DBDSM-III-R Instrument NA MASTNANAPlacebo comparable to int grps

Int grp 1:
Buspirone: 40 mg/day (max)
AA; group and individual counseling encouraged12 wksPlacebo: 29/20

Int grp 1: 28/16
Placebo: 90 %

Int grp 1: 75 %
Placebo: 41.5 (8.0)

Int grp 1: 41.8 (7.6)
NAAnxiety disorder and depressionNoPill count for all groups- MAST
- alcohol use inventory
- drinking behavior interview
- craving scales
- patient diary
- proxy
- GGT
NA10 cm VAS

5-pt OS
Tiihonen J, Ryynanen OP, Kauhanen J, et al. (1996) CT-R-DBDSM-III-R Instrument NAMASTNA >7 daysPlacebo comparable to int grps

Int grp 1:
Citalopram: 40 mg/day (max)
Individual counseling12 wksPlacebo: 31/13

Int grp 1: 31/21
100 %Placebo: 46.8 (8.7)

Int Grp 1: 44.7 (7.0)
NAAnxiety disorder and depressionNoBlood levels in Int grp 1 only- non-std drinking measure
- proxy
NANA

From: Evidence Tables

Cover of Pharmacotherapy for Alcohol Dependence
Pharmacotherapy for Alcohol Dependence.
Evidence Reports/Technology Assessments, No. 3.
West SL, Garbutt JC, Carey TS, et al.

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