Table 93, Summary of study characteristics for naltrexone - Alcohol-Use Disorders

	Oral naltrexone versus placebo	Oral naltrexone versus acamprosate oral naltrexone	Oral naltrexone + sertraline versus oral naltrexone	Oral naltrexone versus topiramate
Total number of trials (total number of participants)	27 RCTs (N = 4296)	4 RCTs (N = 957)	2 RCTs (N = 178)	1 RCT (N = 101)
Study ID	AHMADI2002 ANTON1999 ANTON2005 ANTON2006 BALLDIN2003 BALTIERI2008 CHICK2000B GASTPAR2002 GUARDIA2002 HEINALA2001 HUANG2005 KIEFER2003 KILLEEN2004 KRANZLER2000 KRYSTAL2001 LATT2002 LEE2001 MONTI2001 MORLEY2006 MORRIS2001 OMALLEY1992 OMALLEY2003 OMALLEY2008 OSLIN1997 OSLIN2008 VOLPICELLI1992 VOLPICELLI1997	ANTON2006 KIEFER2003 MORLEY2006 RUBIO2001	FARREN2009 OMALLEY2008	BALTIERI2008
Diagnosis	DSM or ICD diagnosis of alcohol dependence	DSM or ICD diagnosis of alcohol dependence	DSM or ICD diagnosis of alcohol dependence	DSM or ICD diagnosis of alcohol dependence
Baseline severity –units consumed per week	Mean: 98.6 Range: 70.56 to 223	Mean: 128.1 Range: 74.3 to 223	Mean: 83.75 Range: 60 to 107.5	Mean: 263.64
Mean dosage	Naltrexone: 50 mg daily	Naltrexone: 50 mg daily Acamprosate: 1998 mg daily	Naltrexone: 50 mg daily Sertraline: lOOmg daily	Naltrexone: 50 mg daily Topiramate: 300 mg daily
Length of treatment	Range: 12 to 24 weeks	Range: 12 to 52 weeks	Range: 12 to 16 weeks	12 weeks
Length of follow-up	1. Not reported 2. Up to 6 months 3. Not reported 4. Up to 12 months 5–11. Not reported 12. Up to 6 months 13–20. Not reported 21. Up to 6 months 22–27. Not reported	1–3. Not reported 4. Up to 12 months	1–2. Not reported	Not reported
Setting	1–7. Outpatient 8. Inpatient/outpatient 9–11. Outpatient 12. Inpatient/outpatient 13–16. Outpatient 17. Inpatient/outpatient 18–27. Outpatient	1. Outpatient 2. Inpatient/outpatient 3–4. Outpatient	1–2. Outpatient	Outpatient
Treatment goal	1–3. Not reported 4. Abstinence 5–8. Not reported 9. Abstinence 10. Abstinence and drinking reduction/ moderation 11–13. Not reported 14–15. Abstinence 16. Not reported 17. Abstinence 18–20. Not reported 21. Abstinence 22–23. Not reported 24. Abstinence 25–27. Not reported	1. Abstinence 2–3. Not reported 4. Abstinence	1–2. Not reported	Not reported

Oral naltrexone versus placebo

Oral naltrexone versus acamprosate oral naltrexone

Oral naltrexone + sertraline versus oral naltrexone

Oral naltrexone versus topiramate

Total number of trials (total number of participants)

27 RCTs (N = 4296)

4 RCTs (N = 957)

2 RCTs (N = 178)

1 RCT (N = 101)

Study ID

BALTIERI2008

Diagnosis

DSM or ICD diagnosis of alcohol dependence

Baseline severity –units consumed per week

Mean: 98.6
Range: 70.56 to 223

Mean: 128.1
Range: 74.3 to 223

Mean: 83.75
Range: 60 to 107.5

Mean: 263.64

Mean dosage

Naltrexone: 50 mg daily

Naltrexone: 50 mg daily
Acamprosate: 1998 mg daily

Naltrexone: 50 mg daily
Sertraline: lOOmg daily

Naltrexone: 50 mg daily
Topiramate: 300 mg daily

Length of treatment

Range: 12 to 24 weeks

Range: 12 to 52 weeks

Range: 12 to 16 weeks

12 weeks

Length of follow-up

1.: Not reported
2.: Up to 6 months
3.: Not reported
4.: Up to 12 months
5–11.: Not reported
12.: Up to 6 months
13–20.: Not reported
21.: Up to 6 months
22–27.: Not reported

1–3.: Not reported
4.: Up to 12 months

1–2.: Not reported

Not reported

Setting

1–7.: Outpatient
8.: Inpatient/outpatient
9–11.: Outpatient
12.: Inpatient/outpatient
13–16.: Outpatient
17.: Inpatient/outpatient
18–27.: Outpatient

1.: Outpatient
2.: Inpatient/outpatient
3–4.: Outpatient

1–2.: Outpatient

Outpatient

Treatment goal

1–3.: Not reported
4.: Abstinence
5–8.: Not reported
9.: Abstinence
10.: Abstinence and drinking reduction/ moderation
11–13.: Not reported
14–15.: Abstinence
16.: Not reported
17.: Abstinence
18–20.: Not reported
21.: Abstinence
22–23.: Not reported
24.: Abstinence
25–27.: Not reported

1.: Abstinence
2–3.: Not reported
4.: Abstinence

1–2.: Not reported

Not reported

From: 7, PHARMACOLOGICAL INTERVENTIONS

Alcohol-Use Disorders: Diagnosis, Assessment and Management of Harmful Drinking and Alcohol Dependence.

NICE Clinical Guidelines, No. 115.

National Collaborating Centre for Mental Health (UK).

Leicester (UK): British Psychological Society (UK); 2011.

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Table 93Summary of study characteristics for naltrexone