Trial · NCT00338962

Naltrexone & SSRI in Alcoholics With Depression/PTSD

NCT00338962, Phase 3, Completed, Yale University; results first posted 2016-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Naltrexone & SSRI in Alcoholics With Depression/PTSD. Trials, record NCT00338962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00338962

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Naltrexone & SSRI in Alcoholics With Depression/PTSD
NCT number: NCT00338962
Status: Completed
Phases: Phase 3
Enrollment: 88 participants, actual
Lead sponsor: Yale University
Conditions: Alcoholism, Depression, PTSD
Interventions: paroxetine, desipramine, Naltrexone, Placebo
First posted: 2006-06-20
Last updated: 2016-02-05
Results first posted: 2016-02-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	beginning of treatment (week 1), and end of treatment (13 weeks)	The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
Primary	Clinician-Administered PTSD Scale (CAPS)	beginning of treatment (week 1), and end of treatment (13 weeks)	The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD \>80=Extreme PTSD
Primary	Hamilton Depression Rating Scale (HAM-D)	beginning of treatment (week 1), and end of treatment (13 weeks)	The HAM-D ranges from 0 (Normal) to \>23 (Very Severe Depression)
Primary	Mean Number of Side Effects	12 weeks	Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	beginning of treatment (week 1), and end of treatment (13 weeks)	units on a scale	MEAN
PRIMARY	Clinician-Administered PTSD Scale (CAPS)	beginning of treatment (week 1), and end of treatment (13 weeks)	units on a scale	MEAN
PRIMARY	Hamilton Depression Rating Scale (HAM-D)	beginning of treatment (week 1), and end of treatment (13 weeks)	units on a scale	MEAN
PRIMARY	Mean Number of Side Effects	12 weeks	side effects	MEAN

Source ClinicalTrials.gov

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Paroxetine and Naltrexone	Week 1	21.273	Standard Error 2.547	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Paroxetine and Placebo	Week 1	20.700	Standard Error 2.672	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Desipramine and Naltrexone	Week 1	18.500	Standard Error 2.547	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Desipramine and Placebo	Week 1	21.458	Standard Error 2.439	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Paroxetine and Naltrexone	Week 13	10.013	Standard Error 3.009	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Paroxetine and Placebo	Week 13	9.690	Standard Error 3.025	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Desipramine and Naltrexone	Week 13	4.296	Standard Error 2.847	units on a scale
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)	Desipramine and Placebo	Week 13	7.489	Standard Error 2.483	units on a scale
Clinician-Administered PTSD Scale (CAPS)	Paroxetine and Naltrexone	Beginning of Treatment	73.54	Standard Error 5.007	units on a scale
Clinician-Administered PTSD Scale (CAPS)	Paroxetine and Placebo	Beginning of Treatment	69.810	Standard Error 5.166	units on a scale

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Paroxetine and Naltrexone	22
Overall Study	STARTED	Paroxetine and Placebo	20
Overall Study	STARTED	Desipramine and Naltrexone	22
Overall Study	STARTED	Desipramine and Placebo	24
Overall Study	COMPLETED	Paroxetine and Naltrexone	14
Overall Study	COMPLETED	Paroxetine and Placebo	16
Overall Study	COMPLETED	Desipramine and Naltrexone	16
Overall Study	COMPLETED	Desipramine and Placebo	21
Overall Study	NOT COMPLETED	Paroxetine and Naltrexone	8
Overall Study	NOT COMPLETED	Paroxetine and Placebo	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness and Lightheadedness	Nervous system disorders	Paroxetine and Naltrexone	0	22
other	Dizziness and Lightheadedness	Nervous system disorders	Paroxetine and Placebo	0	20
other	Dizziness and Lightheadedness	Nervous system disorders	Desipramine and Naltrexone	2	22
other	Dizziness and Lightheadedness	Nervous system disorders	Desipramine and Placebo	0	24
other	Tachycardia	Cardiac disorders	Paroxetine and Naltrexone	0	22
other	Tachycardia	Cardiac disorders	Paroxetine and Placebo	0	20
other	Tachycardia	Cardiac disorders	Desipramine and Naltrexone	0	22
other	Tachycardia	Cardiac disorders	Desipramine and Placebo	1	24
other	Incarcerated for intoxication	General disorders	Paroxetine and Naltrexone	1	22
other	Incarcerated for intoxication	General disorders	Paroxetine and Placebo	0	20

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Paroxetine and Naltrexone
Total, all-cause mortality	Paroxetine and Placebo
Total, all-cause mortality	Desipramine and Naltrexone
Total, all-cause mortality	Desipramine and Placebo
Total, other adverse events	Paroxetine and Naltrexone	1	22
Total, other adverse events	Paroxetine and Placebo	1	20
Total, other adverse events	Desipramine and Naltrexone	2	22
Total, other adverse events	Desipramine and Placebo	2	24
Total, serious adverse events	Paroxetine and Naltrexone	1	22
Total, serious adverse events	Paroxetine and Placebo	2	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22089316	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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