Trial · NCT01365819
Varenicline for Methamphetamine Dependence
NCT01365819, Phase 2, Completed, University of California, Los Angeles; results first posted 2017-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Varenicline for Methamphetamine Dependence. Trials, record NCT01365819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01365819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Varenicline for Methamphetamine Dependence
- NCT number
- NCT01365819
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- University of California, Los Angeles
- Conditions
- Methamphetamine Dependence, Substance Abuse, Methamphetamine Abuse
- Interventions
- Varenicline, Placebo
- First posted
- 2011-06-03
- Last updated
- 2018-01-18
- Results first posted
- 2017-02-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | End of Treatment Abstinence | 9 weeks | The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo. |
| Secondary | Number of Days Retained in Trial | 9 weeks | Secondary aims will compare treatment retention among participants randomly assigned to receive varenicline or placebo |
| Other | Prevalence of Relapse Following Initiation of Abstinence During Treatment | 7 weeks | 1\) The number of participants who achieve MA abstinence and subsequently relapse to MA use during treatment by condition (varenicline, placebo) during the outpatient treatment period. |
| Other | Reduced MA Withdrawal Symptoms | 9 weeks | 2\) To determine whether varenicline reduces MA withdrawal symptoms more than placebo among MA- dependent participants over the course of the trial. |
| Other | Reduction in Cigarette Smoking | 9 weeks | 3\) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | End of Treatment Abstinence | 9 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Days Retained in Trial | 9 weeks | This outcome was not assessed. | ||
| OTHER_PRE_SPECIFIED | Prevalence of Relapse Following Initiation of Abstinence During Treatment | 7 weeks | This analysis presents the number of participants in each condition who achieved abstinence during treatment and later relapsed. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Reduced MA Withdrawal Symptoms | 9 weeks | This outcome was not assessed. | ||
| OTHER_PRE_SPECIFIED | Reduction in Cigarette Smoking | 9 weeks | This analysis includes a sub-population of participants in both conditions who smoked any cigarettes during treatment. Results are model fitted number of cigarettes smoked per week at baseline and at week 9. | average number of cigarettes | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| End of Treatment Abstinence | Sugar Pill | 5 | Participants | ||
| End of Treatment Abstinence | Varenicline | 4 | Participants | ||
| Prevalence of Relapse Following Initiation of Abstinence During Treatment | Sugar Pill | 6 | Participants | ||
| Prevalence of Relapse Following Initiation of Abstinence During Treatment | Varenicline | 8 | Participants | ||
| Reduction in Cigarette Smoking | Sugar Pill | 19 | Standard Deviation 20 | average number of cigarettes | |
| Reduction in Cigarette Smoking | Varenicline | 1 | Standard Deviation 3 | average number of cigarettes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sugar Pill | 25 | |
| Overall Study | STARTED | Varenicline | 27 | |
| Overall Study | COMPLETED | Sugar Pill | 12 | |
| Overall Study | COMPLETED | Varenicline | 14 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 13 | |
| Overall Study | NOT COMPLETED | Varenicline | 13 |
Source ClinicalTrials.gov
Adverse events8
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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Sugar Pill | 7 | 25 | 9 |
| other | Headache | Nervous system disorders | Varenicline | 10 | 27 | 15 |
| other | Insomnia | Psychiatric disorders | Sugar Pill | 5 | 25 | 7 |
| other | Insomnia | Psychiatric disorders | Varenicline | 9 | 27 | 11 |
| other | Vivid dreams | Psychiatric disorders | Sugar Pill | 5 | 25 | 7 |
| other | Vivid dreams | Psychiatric disorders | Varenicline | 12 | 27 | 15 |
| other | Nausea | Gastrointestinal disorders | Sugar Pill | 5 | 25 | 6 |
| other | Nausea | Gastrointestinal disorders | Varenicline | 10 | 27 | 13 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sugar Pill | ||
| Total, all-cause mortality | Varenicline | ||
| Total, other adverse events | Sugar Pill | 17 | 25 |
| Total, other adverse events | Varenicline | 21 | 27 |
| Total, serious adverse events | Sugar Pill | 0 | 25 |
| Total, serious adverse events | Varenicline | 0 | 27 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sugar Pill vs Varenicline: Prevalence of Relapse Following Initiation of Abstinence During Treatment | Trial comparisons |
| Sugar Pill vs Varenicline: End of Treatment Abstinence | Trial comparisons |
| Sugar Pill vs Varenicline: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01365819
GET https://conductscience.org/api/trials/v1/NCT01365819/registered