Trial Outcomes & Findings for Medication Development in Alcoholism: Acamprosate Versus Naltrexone (NCT NCT00656630)

Results Overview

The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

1 week

Results posted on

2017-03-29

Participant Flow

Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 04/17/2008-12/10/2009. Sixty eight subjects were enrolled, and sixty two subjects completed the study.

Participant milestones

Participant milestones
Measure	Campral (Acamprosate) Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) Placebo: Double-dummy placebo capsules, 1 week duration
Overall Study STARTED	22	27	19
Overall Study COMPLETED	20	25	17
Overall Study NOT COMPLETED	2	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Campral (Acamprosate) n=22 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=27 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=19 Participants Placebo: Double-dummy placebo capsules, 1 week duration	Total n=68 Participants Total of all reporting groups
Age, Continuous	35.73 years STANDARD_DEVIATION 10.10 • n=5 Participants	36.37 years STANDARD_DEVIATION 12.45 • n=7 Participants	42.84 years STANDARD_DEVIATION 10.37 • n=5 Participants	37.97 years STANDARD_DEVIATION 11.42 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	21 Participants n=7 Participants	13 Participants n=5 Participants	46 Participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	27 participants n=7 Participants	19 participants n=5 Participants	68 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 week

The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.

Outcome measures

Outcome measures
Measure	Campral (Acamprosate) n=20 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=25 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=17 Participants Placebo: Double-dummy placebo capsules, 1 week duration
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period Strength	2.12 units on a scale Standard Deviation 3.10	3.40 units on a scale Standard Deviation 3.87	5.86 units on a scale Standard Deviation 4.79
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period Intent	1.65 units on a scale Standard Deviation 1.56	2.99 units on a scale Standard Deviation 3.67	4.22 units on a scale Standard Deviation 4.34
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period Impulse	1.17 units on a scale Standard Deviation 1.94	1.69 units on a scale Standard Deviation 2.78	4.31 units on a scale Standard Deviation 4.82
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period Relief	0.07 units on a scale Standard Deviation 1.67	2.01 units on a scale Standard Deviation 3.56	3.57 units on a scale Standard Deviation 4.14
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period Total	5.00 units on a scale Standard Deviation 6.24	10.09 units on a scale Standard Deviation 12.12	17.96 units on a scale Standard Deviation 15.83

SECONDARY outcome

Timeframe: 1 week

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.

Outcome measures

Outcome measures
Measure	Campral (Acamprosate) n=20 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=25 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=17 Participants Placebo: Double-dummy placebo capsules, 1 week duration
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Baseline	44.90 drinks/week Standard Deviation 61.89	47.02 drinks/week Standard Deviation 24.08	48.87 drinks/week Standard Deviation 58.53
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Week 1	24.37 drinks/week Standard Deviation 22.81	25.79 drinks/week Standard Deviation 14.32	21.51 drinks/week Standard Deviation 18.88
Change From Baseline in Standard Drinks Per Week at 1 Week Drinks/week Change	-20.53 drinks/week Standard Deviation 60.68	-21.23 drinks/week Standard Deviation 23.93	-27.35 drinks/week Standard Deviation 44.84

SECONDARY outcome

Timeframe: 1 week

The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.

Outcome measures

Outcome measures
Measure	Campral (Acamprosate) n=20 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=25 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=17 Participants Placebo: Double-dummy placebo capsules, 1 week duration
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 BDI-II Total Baseline	4.40 units on a scale Standard Deviation 5.14	4.04 units on a scale Standard Deviation 4.33	3.53 units on a scale Standard Deviation 4.74
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 BDI-II Total Week 1	4.75 units on a scale Standard Deviation 4.81	3.84 units on a scale Standard Deviation 4.02	4.94 units on a scale Standard Deviation 5.70
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 BDI-II Total Change	0.35 units on a scale Standard Deviation 4.16	-0.20 units on a scale Standard Deviation 2.84	1.41 units on a scale Standard Deviation 4.30

SECONDARY outcome

Timeframe: 1 week

Population: Seven participants who completed the double blind portion of the trial were unable to be analyzed for change in PSQI Total score due to incomplete PSQI questionnaire at baseline and/or Week 1.

The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.

Outcome measures

Outcome measures
Measure	Campral (Acamprosate) n=16 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=23 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=16 Participants Placebo: Double-dummy placebo capsules, 1 week duration
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 PSQI Total Baseline	4.50 units on a scale Standard Deviation 3.14	4.74 units on a scale Standard Deviation 3.62	4.25 units on a scale Standard Deviation 2.82
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 PSQI Total Week 1	4.69 units on a scale Standard Deviation 3.88	4.57 units on a scale Standard Deviation 3.55	4.38 units on a scale Standard Deviation 3.67
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 PSQI Total Change	0.19 units on a scale Standard Deviation 3.78	-0.17 units on a scale Standard Deviation 2.08	0.13 units on a scale Standard Deviation 2.68

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant in the naltrexone arm who completed the double blind portion of the trial was unable to be analyzed for change in ACQ-SF Total score due to incomplete ACQ-SF questionnaire at Week 1.

The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.

Outcome measures

Outcome measures
Measure	Campral (Acamprosate) n=20 Participants Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	ReVia (Naltrexone) n=24 Participants Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Sugar Pill (Placebo) n=17 Participants Placebo: Double-dummy placebo capsules, 1 week duration
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 ACQ-SF Total Change	-0.44 units on a scale Standard Deviation 1.02	-0.12 units on a scale Standard Deviation 1.56	-0.48 units on a scale Standard Deviation 1.12
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 ACQ-SF Total Screening	3.80 units on a scale Standard Deviation 1.38	3.81 units on a scale Standard Deviation 1.55	3.99 units on a scale Standard Deviation 1.34
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 ACQ-SF Total Week 1	3.36 units on a scale Standard Deviation 1.28	3.69 units on a scale Standard Deviation 1.26	3.51 units on a scale Standard Deviation 0.98

Adverse Events

Acamprosate

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Naltrexone

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acamprosate n=20 participants at risk Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration	Naltrexone n=25 participants at risk Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration	Placebo n=17 participants at risk Placebo: Double-dummy placebo capsules, 1 week duration
General disorders Fatigue	15.0% 3/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Nervous system disorders Headache	5.0% 1/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	8.0% 2/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	5.9% 1/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Gastrointestinal disorders Nausea	5.0% 1/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	12.0% 3/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Gastrointestinal disorders Stomach pain	0.00% 0/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	8.0% 2/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Infections and infestations Nasopharyngitis	10.0% 2/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	8.0% 2/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	5.9% 1/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Psychiatric disorders Depression	10.0% 2/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Gastrointestinal disorders Diaherrea	10.0% 2/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Psychiatric disorders Decreased libido	0.00% 0/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	5.9% 1/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Nervous system disorders Dizziness	5.0% 1/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	8.0% 2/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.
Injury, poisoning and procedural complications Laceration	0.00% 0/20 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/25 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.	5.9% 1/17 • Adverse event data was collected at all four study visits, an average duration of 4 weeks. Adverse events, both serious and other, were documented at all four study visits by the Medical Assistant on the adverse event case report form.

Additional Information

Barbara J. Mason, Ph.D.-Principal Investigator

The Scripps Research Institute

Phone: 858784-7328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place